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Edited Transcript of INFI.OQ earnings conference call or presentation 9-Nov-20 9:30pm GMT

·29 min read

Q3 2020 Infinity Pharmaceuticals Inc Earnings Call Cambridge Nov 9, 2020 (Thomson StreetEvents) -- Edited Transcript of Infinity Pharmaceuticals Inc earnings conference call or presentation Monday, November 9, 2020 at 9:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Adelene Q. Perkins Infinity Pharmaceuticals, Inc. - Chairman & CEO * Brian Schwartz Infinity Pharmaceuticals, Inc. - Consulting Chief Physician * Jayne Kauffman Infinity Pharmaceuticals, Inc. - Senior Executive Coordinator * Lawrence E. Bloch Infinity Pharmaceuticals, Inc. - President & Treasurer ================================================================================ Conference Call Participants ================================================================================ * Matthew Alexander Bannon JPMorgan Chase & Co, Research Division - Analyst * Nicholas M. Abbott Wells Fargo Securities, LLC, Research Division - Director & Associate Analyst * Soumit Roy JonesTrading Institutional Services, LLC, Research Division - VP & Healthcare Analyst ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Ladies and gentlemen, thank you for standing by. Welcome to Infinity Pharmaceuticals Conference Call to discuss the company's operations and financial results for the third quarter 2020. My name is Cathy, and I'll be your operator for today's call. (Operator Instructions). Please be advised that this call is being recorded at Infinity's request. Now I would like to introduce your host for today's call, Jayne Kauffman. Please go ahead. -------------------------------------------------------------------------------- Jayne Kauffman, Infinity Pharmaceuticals, Inc. - Senior Executive Coordinator [2] -------------------------------------------------------------------------------- Thank you, Cathy, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review our third quarter 2020 financial results. On the call with me today are Adelene Perkins, Chief Executive Officer; Larry Bloch, President; and Brian Schwartz, Consulting Chief Physician. We will open up the call for Q&A following our remarks. The press release issued this afternoon details our results and is available on our website at infi.com. Please note that during this call, we may make forward-looking statements about our future expectations and plans. Including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies and financial projections. Our actual results may differ materially from what we project today, due to a number of important factors, including the considerations described in the Risk Factors section of our quarterly report on Form 10-Q for the third quarter of 2020 and in other filings we make with the SEC. These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information, future events or otherwise. Now I would like to turn the call over to Adelene. -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [3] -------------------------------------------------------------------------------- Thanks, Jayne, and thank you to everyone for joining us today. We are reaching an exciting inflection point in Infinity having progressed the development of eganelisib towards data readouts across our clinical programs in diverse treatment settings and indications, strategically designed to evaluate the potential of eganelisib to improve outcomes for cancer patients. Over the past 2 years, we have focused on the execution of our Phase-II clinical trial, leveraging the strong scientific foundation of PI3-kinase-gamma inhibition with eganelisib. And are now positioned to deliver important clinical and translational data in the coming months. On today's call, our consultant chief physician, Dr. Brian Schwartz, will provide more detailed clinical update. But before that, I'd like to review some highlights from the past quarter. Starting off with MARIO-275, our randomized controlled Phase-II study in collaboration with BMS in which we are evaluating eganelisib in combination with Opdivo in patients with advanced urothelial cancer. We previously announced that we reduced the dose of eganelisib from 40-milligrams to 30-milligrams daily to address the reversible liver enzyme elevation, which were reported at the first scheduled IDMC meeting last spring. We've continued treatment of patients still on study at 30 milligrams and have continued monitoring the safety of the 49 patients enrolled in the study today. And we recently reviewed updated data from these patients with the IDMC. We're pleased that the IDMC concluded that the risk-benefit ratio of eganelisib and Opdivo in this patient population warrants ongoing evaluation. We will continue to follow the patients still on study through year-end and evaluate data on maturing time-to-event measures, including progression-free survival and overall survival to determine the best path forward for eganelisib plus Opdivo in second-line bladder cancer. I will now move to MARIO-3, our Phase-II study in collaboration with Roche/Genentech in which we are evaluating the combination of eganelisib with Tecentriq and Abraxane as a front-line treatment in patients with triple-negative breast cancer or TNBC, and in combination with Tecentriq and Avastin, as a frontline treatment for patients with renal cell cancer or RCC. Last quarter, we shared that we were on track to present data from the TNBC cohort of MARIO-3 and have been accepted to present these results at the San Antonio Breast Cancer Symposium or SABCS next month. We were also pleased to have received Fast Track Designation for eganelisib in combination with the checkpoint inhibitor and chemotherapy for first-line treatment of patients with advanced TNBC. This week, at SITC, our investigators are presenting updated data from the melanoma and squamous cell cancer of the head and neck cohort of MARIO-1, our Phase I/Ib study in collaboration with Bristol-Myers Squibb, evaluating eganelisib in combination with Opdivo in patients with advanced solid tumors. These data supports the tolerability and activity of this combination and provide additional translational data supporting both the on mechanism immunomodulation of eganelisib and our clinical strategy to move eganelisib to earlier lines of treatment. And finally, in addition to these Infinity sponsored trials, our collaborator, Arcus Biosciences, will also be presenting data at SABCS from their Phase Ib study evaluating eganelisib in a novel checkpoint inhibitor free regimen that includes etrumadenant, their dual receptor antagonist, the adenosine antagonist, also known as AB928, and Doxil in patients with relapsed/refractory triple-negative breast cancer, adding to our eganelisib data set in TNBC. We are pleased with our progress in the clinic, which enables us to share data over the coming months, that reveal the potential of eganelisib. We're grateful for the commitment and dedication of our employees, collaborators and partners who've enabled this progress. With that overview, I will now transition the call over to Brian to provide more detail on our trials and upcoming data presentations. -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [4] -------------------------------------------------------------------------------- Thank you, Adelene. These are exciting times at Infinity and we are looking forward to sharing our progress and data. Starting out with an update on MARIO-3. As Adelene mentioned, we have 2 cohorts in this ongoing Phase II study. One evaluating eganelisib in combination with Tecentriq and Abraxane as a frontline therapy for triple-negative breast cancer patients, for which we have received Fast Track Designation from the FDA and the other evaluating eganelisib in combination with Tecentriq and Avastin as a front-line therapy for patients with renal cell cancer. Last quarter, we shared that we have generated encouraging signals of clinical activity in the triple-negative breast cancer cohort. Today, I am happy to share that we will be presenting these data at the San Antonio Breast Cancer Symposium in December. At this symposium, we will be presenting data from our front-line MARIO-3 triple-negative breast cancer cohort together with an update on enrollment, enrollment outlook for this cohort. And also, Arcus will be presenting data in the second line triple-negative breast cancer setting as well. Taken together, we believe that we may have the unique opportunity with eganelisib to make an impact in triple-negative breast cancer, the deadliest form of breast cancer with limited treatment options. We have also made progress in the RCC cohort of MARIO-3, having completed enrollment ahead of schedule with 30 patients enrolled across approximately 25 sites. Moving next to MARIO-275, which is our controlled, randomized Phase II study, evaluating eganelisib in combination with Opdivo in platinum refractory IO-naive patients with advanced urothelial cancer. This is run in collaboration with Bristol-Myers Squibb. As we previously reported, we implemented a dose reduction from 40 milligrams once-a-day to 30 milligrams once-a-day to address the reversible liver function elevations identified at the first IDMC meeting. We were pleased that this dose reduction was successful enabling the continued treatment of patients previously enrolled in the study. We have continued treating patients previously enrolled in the study and presented updated data from these patients at our latest IDMC meeting. After reviewing these data, the IDMC concluded that the risk-benefit to patients supported and continued evaluation of eganelisib plus Opdivo in this patient population and supported reopening of enrollment of MARIO-275. We are pleased that the 30-milligram dose is well tolerated and are confident in moving forward at this dose from an efficacy perspective with PK data that shows near complete to sustained inhibition of PI3K-gamma with eganelisib monotherapy at doses of 50 milligrams once-daily and above as well as robust PD markers of activity at the 30-milligram dose. So what is our path forward in metastatic urothelial cancer? We are continuing to evaluating the clinical benefits in patients currently enrolled in MARIO-275 across maturing time-to-event measures, including progression-free survival and overall survival through the end of the year to inform next steps. Our path forward may include reopening enrollment of MARIO-275 to generate additional data or leveraging the clinical and translational insights from the first 49 patients to design a follow-on study. And finally, we are presenting data this week at SITC from MARIO-1. Our Phase I/Ib study in collaboration with Bristol-Myers Squibb, which enrolled a bunch of patients with advanced solid tumors. As a reminder, the melanoma and squamous cell cancer, head and neck cohorts of MARIO-1 were designed to carefully isolate the clinical benefits of eganelisib by examining its clinical activity in patients who are not expected to respond to checkpoint inhibitor monotherapy while having progressed on checkpoint inhibitor as their immediate prior therapy. By targeting these patients, not expected to respond to checkpoint inhibitor monotherapy, we put eganelisib in a difficult test to ensure that patient benefits observed can be attributed to the addition and contribution of eganelisib making any disease control in these patients meaningful. In a poster presented by our collaborators at Memorial Sloan Kettering on the melanoma cohort at SITC, we reported that eganelisib in combination with nivolumab was generally well tolerated and associated with the safety -- but favorable safety profile. We are pleased to see clinical activity in patients who are not expected to respond to checkpoint inhibitor monotherapy immediately prior -- that they progressed on immediately prior to coming on to treatment. Most encouraging, disease control was observed in more than half or 52.6% of the 19 patients who had been refractory or relapsed to checkpoint inhibitor therapy following 2 or fewer prior lines of therapy with a partial response rate of 21%. Importantly, we demonstrated that we hope -- what we hope to show in the study the reversible of progressive disease in patients with immediate prior treatment with anti-PD-1 PD-L1 therapy. When we look at the translational data from the cohort, we see on mechanism effects of eganelisib, decreasing immune suppression, reflected in reduced MDSC levels and increased immune activation via T-cell invigoration and upregulation of interferon-gamma responsive factors. The data from squamous cell carcinoma of the head and neck cohort which were presented in an oral presentation from our collaborators at UCSD at SITC were similar to what we observed in the melanoma cohort. As in the menaloma cohort, the combination of treatment with eganelisib and nivolumab was generally well tolerated and had a favorable safety profile. In addition, we see clinical activity in patients not expected to benefit from checkpoint inhibitor monotherapy due to immediate prior progression on a checkpoint inhibitor. Disease control was observed here in 45% or 9 of the 20 evaluable patients with partial responses in 10% or 2 out of 20 evaluable patients who had been refractory to or relapsed on a median checkpoint inhibitor therapy. Just as seen in the melanoma cohort, patients with 2 or fewer prior lines of therapy had a greater clinical benefit with 20% or 2 of the 10 evaluable patients achieving a partial response. These results are meaningful for a few reasons. First and foremost, we see an excellent safety profile. Second, we see an on-mechanism activity with immune modulation as intended with treatment. Thirdly, as we just mentioned, we saw clinical activity with a considerable disease control rate in patients who progressed on or immediately prior to checkpoint inhibitor therapy. Having deliberately set a very high bar for activity in this setting we are pleased with the contribution of eganelisib in improving outcomes of these patients. And finally, in both cohorts, we see the greatest clinical benefit in patients that received 2 or fewer prior lines of therapy. This is important validation of our overall clinical strategy in which we have moved eganelisib to earlier lines of therapy in our ongoing studies, in second-line urothelial cancer in MARIO-275 and and in the frontline setting in triple-negative breast cancer and renal cell cancer in MARIO-3. In summary, the data for MARIO-1 suggests that eganelisib can potentially be safe and well tolerated immunotherapy capable of improving meaningful clinical benefits in multiple cancer types and treatment regimens. Overall, we are encouraged with our progress across our clinical program. And despite the challenges associated with COVID-19, we have been able to continue the treatment of patients with limited disruptions. In the coming months, we look forward to sharing the data across our programs, which will highlight the potential of eganelisib as a unique macrophage targeted treatment to expand the benefit of immunotherapy to diverse patients across indications and settings. Before I transition the call over to Larry, I would like to thank our patients, investigator, collaborators at BMS, Roche/Genentech and Arcus, whose continued dedication has enabled our clinical progress. With that, I will turn it over to Larry. -------------------------------------------------------------------------------- Lawrence E. Bloch, Infinity Pharmaceuticals, Inc. - President & Treasurer [5] -------------------------------------------------------------------------------- Thank you, Brian. Turning to our third quarter financial results. At September 30, 2020, Infinity had total cash, cash equivalents and available for sale securities of $41.3 million as compared to $42.7 million at June 30, 2020. The R&D expenses for the third quarter of 2020 were $6.1 million compared to $7.1 million for the same period in 2019. And this decrease is primarily related to a combination drug purchase during the third quarter of 2019. G&A expense was $2.9 million for the third quarter of 2020 and as compared to $3.6 million for the same period in 2019. And this decrease is primarily related to a reduction in professional services as well as consulting expenses. And net loss for third quarter 2020 was $9.5 million or a basic and diluted loss per common share of $0.16 compared to a net loss of $11.4 million or a basic and diluted loss per common share of $0.20 for the same period in 2019. We expect to end 2020, with the cash and investment balance ranging from $25 million to $35 million and based on our current operating plans, which exclude additional funding or business development activities, we anticipate that our existing cash, cash equivalents, and available-for-sale securities will be adequate to satisfy our capital needs through 2021. Infinity's financial guidance does not include potential additional funding or business development activities a potential $5 million milestone payment from BVF based on PellePharm's ongoing Phase III clinical trial of patidegib topical gel in Gorlin Syndrome, or any milestones from or the sale of the company's equity interest in PellePharm. We're very appreciative of your continued support as we move forward with development of eganelisib and look forward to providing our next update on eganelisib development at the San Antonio Breast Cancer Symposium next month. At this time, we can open the call for questions. Operator? ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions). And your first question is from Anupam Rama from JPMorgan. -------------------------------------------------------------------------------- Matthew Alexander Bannon, JPMorgan Chase & Co, Research Division - Analyst [2] -------------------------------------------------------------------------------- This is Matt Bannon on for Anupam. So I thought it was really interesting in the MARIO-1 data set presented at SITC. Just how starkly responses are bifurcated between patients with 2 or fewer prior lines of therapy versus those with 3 or more. And within the responding patient, besides 1 blip in the chart for patient A with stage 3 melanoma, I'm referring to the time series of objective responses. There seem to be a consistent trend in the size of target lesions from baseline and that they almost exponentially shrink before plateauing and eventually coming back in size? So 2 questions on this. The first is where any biopsy is taken in these responders as their tumors were increasing in size that might shed light on the specific resistance mechanisms that these tumors are using to overcome therapy? And secondly, are these the response dynamics that you would expect in other tumor types? Or just trying to think about the read-through here. -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [3] -------------------------------------------------------------------------------- Sure. I'll start, and then I'll turn it over to Brian. Thanks for your question, Matt. First, your point is well taken in terms of the patients in MARIO-1, in both our melanoma and our head and neck, we're really challenging patients for 2 reasons. First is that they had all progressed on a checkpoint and their immediate prior. And then the second was that they were really late stage. So the melanoma poster, as you saw, 50% of the patients had 4 or more prior therapies. So this is a really sick, really late-stage patient population. So it's not surprising that we saw the better responses in the patients who have 2 or fewer, and even that's pretty remarkable, given that they had -- as you can see from the little patients in yet, it's a real reversal of progression on a checkpoint inhibitor to a reduction. So that's not completely surprising, and it's very consistent with our strategy. As Brian mentioned in his remarks, of moving into the second line in bladder cancer and in the frontline in TNBC. So we would expect that. Brian, maybe you can speak to the -- any further insights on resistance mechanisms. -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [4] -------------------------------------------------------------------------------- So unfortunately, there are not many paid biopsies to highlight the potential resistance mechanisms that could potentially develop over time but I think important, as you highlighted, for patients who were progressing, who had received immunotherapy as their last therapy and just had the addition of eganelisib, one wouldn't have expected an additional response to occur. And that was the interesting and exciting phenomenon that we observed in this trial. But you're correct in the other trials, we hopefully will try and get more biopsies on progression and better learn the changes in different key immune-related cells and responses that could better inform us as to why the patient's tumors start regrowing. -------------------------------------------------------------------------------- Operator [5] -------------------------------------------------------------------------------- Next question is from Jim Birchenough of Wells Fargo. -------------------------------------------------------------------------------- Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Director & Associate Analyst [6] -------------------------------------------------------------------------------- It's Nick on for Jim (inaudible). Congratulations on the data update. First question and it's probably passing words in a way you don't want them passed. But in terms of the IDMC thing, risk benefits that supports continuation of the study. Does that suggest that there was -- I suggest there was an assessment of benefit. Does that connote a futility analysis? -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [7] -------------------------------------------------------------------------------- So I -- go ahead, Brian. -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [8] -------------------------------------------------------------------------------- No, it's okay. Go ahead, Adelene. That's fine. I'll come in then. -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [9] -------------------------------------------------------------------------------- Yes, I was just going to say, it definitely does denote an efficacy analysis. We didn't have a preestablished futility, but we were looking at is there evidence, one beauty is, of course, of a controlled trial is that you see the differences both in any AE signals, which was the reason that we did the pause in May, but we also can see a benefit on the treatment on versus the control arm. And so we did see both that at 30 milligrams, it was better tolerated, and we have evidence of a benefit of the combination of eganelisib and Opdivo versus the control arm of Opdivo and placebo. -------------------------------------------------------------------------------- Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Director & Associate Analyst [10] -------------------------------------------------------------------------------- And then, Adelene, as you think about next steps here, you've suggested we could either reopen this study or we could take what we've learned from this study and the other studies and initiate a new trial. So I mean, where you're sitting today, which of those 2 options do you prefer? And why? -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [11] -------------------------------------------------------------------------------- It's -- Nick, as you know, it's going to be completely data dependent. So we're encouraged by the data that we've got to date. We're going to continue to look at that because it's progressing on both 2 really important metrics of PFS and OS. And when we look at that data, that will inform our next step of which is preferable. So it's just premature in the absence of having that data over the next couple of months to know which is preferable. -------------------------------------------------------------------------------- Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Director & Associate Analyst [12] -------------------------------------------------------------------------------- And then going back to the melanoma poster. Just very quickly, can you comment on baseline MDSC in these patients and whether there was any correlation between elevated levels and activity. And then we have 2 patients respond already quite quickly. And then 2 patients achieved a PR after at least 6 months of treatment. So what are your thoughts underlying the biology of what's going on here? -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [13] -------------------------------------------------------------------------------- I'll take a first crack, and then, Brian, I'm sure you can elaborate more. What we did see in terms of the underlying mechanism. And on the poster, it's really captured in some of the graphs that are right below the patient vignettes, where we did see in the vast majority of patients that are treated, a reduction in MDSCs, which is what we'd expect, and we've seen that consistently throughout all of our data to date. We see that leading, and that happened in just the first month. We see that leading to a pretty significant increase in the proliferation of previously exhausted T cells. So we see this activation of T cells and then we see all the markers of an immune response. So we've got the data there, CXCL9, CXCL10. And then on the poster underneath the cartoon of the mechanism of action, there's a table. And what we've seen and presented is one of the most upregulated genes is [CD 274], which is reflective of PD-L1. So we see that with the upregulation of immune response, that there's an upregulation of PD-L1 to try to blunt that T cell response. In some ways, we see that kind of priming for the checkpoint inhibitor by upregulating where there's data. As you know, across lots of different tumor types that patients do better on a checkpoint inhibitor, the higher their PD-L1 expression. So that's a concept that regardless of whether the patient started with high or low PL-1, if we upregulate that, that's going to -- we believe, is part of the reason for increased activity of the checkpoint inhibitor. So what we've been encouraged by in both the MARIO-1 data that we're presenting at SITC this week and some of the data that we'll be presenting in the coming months is that the activity that we're seeing is completely consistent with our understanding of the biology of PI3-kinase gamma and what inhibiting it should do in terms of activating an immune response. -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [14] -------------------------------------------------------------------------------- Yes. I think the other important thing to remember is we have 2 sets of biomarkers. We have the circulating biomarker that's showing the poster, the circulating MDSCs and then we have what's -- or the different markers of T-cell reinvigoration. And then we have what's going on in the tumor. So what we've really tried to do in MARIO-3 and in MARIO-275, is trying to understand better what's going on in the tumor as well. And maybe that will become a better correlation as we move forward. But we have an idea of what's going on in the peripheral blood, but we really don't have a very good idea in terms of the biomarker in terms of what's going on in the tumor. And that's what we're trying to get. And we have some additional studies where we're really going to try and elucidate what happens in the tumor micro environment. -------------------------------------------------------------------------------- Operator [15] -------------------------------------------------------------------------------- Your next question is from Andrew D'Silva of B. Riley. -------------------------------------------------------------------------------- Unidentified Analyst, [16] -------------------------------------------------------------------------------- This is Noreen (inaudible) on for Andy. So forgive me, if you've actually mentioned this before, but I was just wondering with regard to MARIO-1, were there any other tumor types where hepatotoxicity has been seen. Now looking back seeing what you've seen with MARIO-275, did you observe any of that? Or have you observed long term, any liver enzyme elevations? -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [17] -------------------------------------------------------------------------------- I can take that. In terms of liver enzyme elevations, we all know there's around 10-ish percent increase in transaminases autoimmune based with immunotherapy, and with single agent, we have a little bit of data at 40 and 60, suggesting that the drug itself could cause an increase in transaminases. Across the different cohorts, and we have multiple different cohorts in the Phase I trial, for example, you'll see in the melanoma cohort, we had an incidence of AST/ALT increase [present]. And then in the squamous cell, head and neck cohort, there was very, very little. So I think it varied amongst tumor type. What made it much clearer was in a randomized setting where you took immunotherapy versus immunotherapy plus eganelisib, where you could really tease out the difference. Numbers were still small, but it became really apparent. There was a difference when one looked in that randomized setting. -------------------------------------------------------------------------------- Unidentified Analyst, [18] -------------------------------------------------------------------------------- Right. That's really helpful. And then in terms of the MARIO-3 trial in triple-negative breast cancer, can you remind us what the benchmark is in terms of the response rates? And maybe share what internal bar you might have looking at those response rates? -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [19] -------------------------------------------------------------------------------- So if you look if you look at MARIO-3 (inaudible), 3 in the triple-negative breast cancer, we'll have 2 cohorts. It will have a cohort with PD-L1 high and a cohort with PD-L1 low. So PD-L1 low is easy. The bar is relatively low. And even though there is a response rate of around 40-ish percent with Abraxane, the approval is only for the PD-L1 high. So I think we're looking at for the PD-L1 low at PFS to beat the PFS of -- it's 5 months for the PD-L1 low with a response rate of about 40. And for the PD-L1 group, just over 50% response rate a PFS of about 7.8 months. So I think we're trying to look at the totality of the data, both the -- what I call it, the depth of the responses and the duration of the responses and the totality of the data that we're looking at in the triple-negative breast cancer cohort. -------------------------------------------------------------------------------- Unidentified Analyst, [20] -------------------------------------------------------------------------------- Great. And just one last one. So in the same study in the triple-negative breast cancer, at SABCS, what kind of data actually will you be presenting? Can you provide some guidance on that, like patient number, et cetera? -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [21] -------------------------------------------------------------------------------- So [Normie], we haven't provided the patient numbers, although, obviously, we will be updating those at [SABCS]. And what we'll be presenting is all the data that we have on the patients that are enrolled to date up through the data cutoff that we needed to. So it will include time on study and response rate as well as the safety update for all those patients who are on study and have had a first scan at this point. I'll also just remind you, (inaudible), that the reason that Brian shared those benchmarks of the (inaudible) Abraxane in the PD-L1 positive study for which they have accelerated approval. We did design MARIO-3 to mirror that approval study IMpassion130 as closely as possible. So we have all the same inclusion, exclusion criteria. So it's not a randomized study. It's a pretty good benchmark for us. -------------------------------------------------------------------------------- Operator [22] -------------------------------------------------------------------------------- Our next question is from Soumit Roy of JonesTrading. -------------------------------------------------------------------------------- Soumit Roy, JonesTrading Institutional Services, LLC, Research Division - VP & Healthcare Analyst [23] -------------------------------------------------------------------------------- Congratulations on the very promising data. Looking at the SITC poster at the MDSC levels, could you give us a little color on how the trend look like in the MDSC levels passed cycle too, if you're collecting those data because historically, prior trials, you have done it very nicely correlates with the partial response. And the responders, could you tell us the PD-L1 status on these patients with the high or low in the melanoma trial? -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [24] -------------------------------------------------------------------------------- So 2 things. One is, unfortunately, we don't have the PD-L1 status on a lot of the patients from MARIO-1 so we're basically in the melanoma trial, we've all the available pertinent data we have put in the poster so unfortunately, we just don't have all that data. The second part about MDSCs over time in the newer studies, we're collecting it, but it is quite variable. And we'd like to sort of summarize a much bigger cohort of patients before we make any conclusions about long-term changes in MDSC levels we're circulating ones. Once again, I'll reiterate what I said a little bit earlier on, really interested to see what happens in the tumor to see how the different markets change there. -------------------------------------------------------------------------------- Soumit Roy, JonesTrading Institutional Services, LLC, Research Division - VP & Healthcare Analyst [25] -------------------------------------------------------------------------------- Okay. And could you remind us the MARIO-3 and the dosage you're using is continuing to be 40 or 30 going forward? -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [26] -------------------------------------------------------------------------------- So we've expanded it at 30 for MARIO-3 looking at the totality of the data and all the different parameters that we assess, we feel comfortable, as we've stated before that this sufficient drug is a sufficient PD effect. So feel comfortable at 30 milligrams moving forward. And we do know that as we increase the dose, these are higher incidence of transaminases. So that has been a really well tolerated dose, the 30. Some of the Arcus data will be presented at 40 milligrams at San Antonio Breast but they did a cohort of 30 and 40 milligrams. -------------------------------------------------------------------------------- Operator [27] -------------------------------------------------------------------------------- Your next question is from Kevin DeGeeter of Oppenheimer. -------------------------------------------------------------------------------- Unidentified Analyst, [28] -------------------------------------------------------------------------------- This is Susan on for Kevin. I wanted to follow-up on getting any details on the potential follow-on study for Mario-275. I know that you want to look at the data before you decide to enroll. But what would be the study objective and, I guess, patient population? -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [29] -------------------------------------------------------------------------------- So we understand your question, it really is going to be a function of the data itself what we would try to do is mirror -- take the learning from MARIO-275 in terms of the patients that has benefited most significantly and build a trial that leverages that data. So that's the focus and the objective of the study will be a function of what the data are and what past that those data pay for us in the next step. -------------------------------------------------------------------------------- Unidentified Analyst, [30] -------------------------------------------------------------------------------- Okay. Great. That makes sense. And my second question is on the MARIO-3 enrollment. You mentioned in your press release that you had implemented a number of initiatives. Can you give us color on what those initiatives are? And if you plan to disclose any metrics on enrollment? -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [31] -------------------------------------------------------------------------------- So we certainly will be providing at San Antonio an update on what current enrollment is as well as our outlook on enrollment. We're working very closely with our CRO and our sites. We've done a number of things that include a social media campaign so that patients will have access with a search for our trial. We've done a number of calls and educational sessions with our site. Brian, is there anything else that you would highlight that we've done? -------------------------------------------------------------------------------- Brian Schwartz, Infinity Pharmaceuticals, Inc. - Consulting Chief Physician [32] -------------------------------------------------------------------------------- I think that's -- I think it's a very competitive area. But I think (inaudible) -- will give you some more color, but it does seem to be a problem at the moment. -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [33] -------------------------------------------------------------------------------- And we think, ultimately, to your question, Susan, we think what we'll facilitate enrollment the most is through data. And so as our data mature, getting that data out, we will (inaudible) the most impossible driver of enrollment. -------------------------------------------------------------------------------- Operator [34] -------------------------------------------------------------------------------- Thank you. At this time, I'm showing no further questions. I'd like to turn the call back over to Adelene for closing remarks. -------------------------------------------------------------------------------- Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [35] -------------------------------------------------------------------------------- Thank you. We're really excited to have reached this important phase of development in Infinity, and we look forward to sharing data and updates in the coming months. We thank you for your continued support and for joining today's call and to updating you later this year. Thank you and have a nice night. -------------------------------------------------------------------------------- Operator [36] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference call. You may now disconnect.