but what if SAFM beats on earnings? I would think there is opportunity fr a big pop. With feed prices down, it is quite possible for a beat.
This is a monthly journal sent to hematologists and oncologists monthly:
SAN FRANCISCO — Mark R. Litzow, MD, professor of medicine at Mayo Clinic and chair of the ECOG-ACRIN Leukemia Committee, highlights data demonstrating that combination therapy with vosaroxin and cytarabine was associated with longer OS in patients with acute myeloid leukemia.
Litzow noted that the phase 3 double-blind randomized controlled VALOR study showed benefit of survival in patients with first-relapsed or refractory AML who received vosaroxin.
According to study results, median OS was 7.5 months for vosaroxin compared with 6.1 months for placebo, with a complete response rate of 30.1% for vosaroxin vs. 16.3% for placebo.
“I think this drug did show benefit and I think it adds a potential new agent to our treatment of patients who are in a very difficult situation with relapsed or refractory AML,” Litzow told HemOnc Today. “Whether this will ultimately get approved by the FDA, we’ll need to see, but I think the results are favorable enough that it should be given serious enough consideration.”
Steensma invited Ravandi to comment, who responded that he thinks of AML as being equivalent to metastatic cancer: “Patients with relapsed AML present with disease all over their body from day one. In solid tumors we are excited about a one- or two-month improvement in survival; I don't see why we shouldn't be excited about that in AML as well,” he said.“And we have set the bar high for ourselves in AML with about 40 percent of patients cured. You don't see 40 percent cure in metastatic cancers. This improvement in AML is highly significant—we should not discount the small steps forward in treating our patients and providing them better treatment options.”Asked for her perspective for this article, Anjali Advani, MD, Director of the In-Patient Leukemia Unit and Associate Professor at Cleveland Clinic Lerner College of Medicine, said it is encouraging to see responses like this in such a poor-risk population.Still, she said it is important to keep in mind that the dosing of cytarabine used in VALOR was lower than that typically used for salvage in relapse-refractory AML. “However, this modified dosing was likely used to be able to encompass an older population,” she noted.Advani called the results encouraging: “This is a poor-risk population, and they did include older patients.”One question is whether the responses would have been better in the standard arm with a higher dose of cytarabine, particularly for younger patients, she added. “What would have happened to the experimental arm in that setting?”Patients in the trial were stratified between the two arms for allogeneic transplant, which was not mandated, Advani noted. “For patients who ultimately relapse, even though they can get back into remission with more chemotherapy, that remission is not going to be durable without an allogeneic bone hematopoietic stem cell transplant.”
Dear Dr. Ellman,
You heard correct that one of our patients in our PK trial received 21 cycles of aldoxorubicin. The dose was 230mg/m2 (170mg/m2 doxorubicin equivalents) and the small cell lung cancer patient had progressed following platinum plus etoposide.
VP, Business Development & Investor Relations
This certainly bodes well for the ph3 study where aldox is given until dz progression vs. fixed amount of dox.
The FDA just approved Novartis" new drug for multiple myeloma on basis of sub-groupp analysis:
The US Food and Drug Administration (FDA) today granted accelerated approval to panobinostat (Farydak, Novartis) for the treatment of patients with relapsed multiple myeloma.
Late last year, panobinostat was voted down at an FDA Oncologic Drugs Advisory Committee meeting that had considered its use in relapsed multiple myeloma. The agency said that after that meeting the company submitted additional information supporting the agent's use for a slightly different indication, and it was this that was approved.
The approval is for use of the panobinostat in patients with relapsed multiple myeloma who have received at least two prior standard therapies, including bortezomib (Velcade, Millennium) and an immunomodulatory agent. This is an area of unmet medical need, the company noted.
Panobinostat is approved for use in combination with bortezomib and dexamethasone.
The drug is a first in a new class of agents that act as inhibitors of histone deacetylases.
"Panobinostat has a new mechanism of action that distinguishes it from prior drugs approved to treat multiple myeloma, making it a potentially attractive candidate agent," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement. This FDA approval is based on efficacy and safety data in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an immunomodulatory agent. This subgroup of patients participated in the phase 3, randomized, double-blind, placebo-controlled, multicenter global registration trial, known as PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA).
The findings showed that, in this subgroup, the median progression-free survival in patients treated with panobinostat was higher than that in the placebo arm (10.6 months, n = 94 vs 5.8 months, n = 99; hazard ra
Valor's data barely missed statistical significance for the entire study BUT were stunning in the pre-defined sub-set of patients 60 and in those with short remissions. The FDA appears to have set a precedent with the NVS drug just approved for multiple myeloma in approval based on a sub-set group. Hence, things look more favorable for FDA approval for vosaroxin based on its sub-set success.
An Editorial on the article by Jacobs in this month's issue of BLOOD- the Journal of the American Society of Hematology:
Although most investigators are well aware of the incredible success of brentuximab vedotin in the treatment of patients with Hodgkin lymphoma (HL)1 and anaplastic large-cell lymphoma (ALCL),2 the study by Jacobsen and colleagues in this issue of Blood demonstrates surprising activity of this agent in patients with B-cell non-Hodgkin lymphoma (NHL).3
In a planned subset analysis of a phase 2 multicenter trial of brentuximab vedotin in patients with relapsed/refractory CD30+ NHL, overall response (OR) and complete response (CR) rates of 44% and 17%, respectively, were observed in 49 patients with diffuse large B-cell lymphoma (DLBCL). Although only 20% of the enrolled DLBCL patients had a prior autologous transplant, 82% were refractory to prior therapy and 24% were transformed from low-grade NHL. OR was 44% and 50% in the patients with refractory and transformed DLBCL, respectively. This efficacy rivals that of other single agents in DLBCL, namely lenalidomide and ibrutinib, where ORs of 22% to 53% have been described.4⇓-6
Nineteen patients with B-cell NHL other than DLBCL were also enrolled. Seventy-four percent of these patients were refractory to their last therapy, and OR in this group was 26%, with responses observed in patients with gray-zone lymphoma (n = 3), primary mediastinal B-cell lymphoma (PMBCL, n = 1), and posttransplant lymphoproliferative disorder (n = 1).
Three questions arise in reviewing this study: (1) Can we predict response based on CD30 expression; (2) Why is the activity in PMBCL so low (overall response rate 17%), particularly w
With respect to question 1, patients who entered this study were required to have visible CD30 expression by immunohistochemistry (IHC) analysis in a relapse biopsy sample reviewed by a local pathologist. This tissue was also sent for central pathology review, where CD30 expression on the neoplastic cells was visually quantified, and for analysis using computer-assisted quantification of CD30 expression on all cells (malignant and nonmalignant) in a specimen. Surprisingly, no statistical correlation between response and CD30 expression by central visual IHC or by computer-assisted review was observed. Specifically, in 48 DLBCL patients, the median percent of CD30+ cells by visual central review was 25% (0, 90) in the responders vs 25% (0, 100) in the nonresponders. Twenty-one percent of the responders had
Sentiment: Strong Buy
In regards to the second question, the authors acknowledge that only 1 of 6 responses in patients with PMBCL is unexpectedly low, but owing to the limited numbers of these patients, they are unable to address this question further. Although accrual of PMBCL patients to a phase 2 trial with brentuximab vedotin may be challenging because of the rarity of this disease and the relatively high response rates with standard front-line regimens, such a study is needed. Patients with PMBCL who relapse are often particularly challenging to salvage because the disease tends to be quite aggressive and chemo-refractory, providing a clinical rationale for novel therapies in this patient population.
Finally, addressing the third question, the study by Jacobsen et al did not assess cell of origin, myc, or bcl-2 expression in the DLBCL patients. Therefore, it is unclear whether response is associated with a specific DLBCL subtype as is observed with lenalidomide and ibrutinib, where OR is higher in the activated B-cell subtype. However, in a recent study by Hu et al, 461 cases of de novo DLBCL (PMBCL was excluded) were assessed for CD30 expression, and 14% were found to have CD30 expression of at least 20%.9 Of these 65 cases, 38, 26, and 1 were germinal-center, activated B cell, or unclassifiable, respectively, by gene expression profiling. None of the CD30+ cases had a detectable myc translocation by fluorescence in situ hybridization, although 38, 26, and 15 patients were found to have myc, bcl-2, or both myc and bcl-2 overexpression by IHC analysis. Moreover, CD30+ patients had a superior overall survival and progression-free survival, with 5-year overall survival and progression-free survival of 79% and 73%, respectively, in the CD30+ group compared with 59% and 57% for the CD30– cases. The favorable outcome of the CD30+ patients was observed regardless of cell of origin. The studies by Hu et al and others demonstrate that we still have a lot to learn about how best to use the
Stock seems way undervalued by every metric. Unfortunately, my sense is that management is very conservative and unlikely to make a significant special dividend or borrow$$ to initiate a share buy back
You are wrong! SNSS hopes to get FDA approval based on approval of a pre-defined sub-group of 60 years old, which was highly statistically significant. The head of FDA Heme/Onc Division, Richard Pazdur, seems much more amenable to approving a sub-group that demonstrates OS, which is the toughest parameter to obtain in a study.
just completed Palestine, Tx plant and starting new plant, all WITHOUT debt. Patience will win out here. Also a good chance that they will be bought out as the smallest co. in the field.
MEIP dropped 66% this morning after disclosing the failure of its drug, pracinostat in ph2, to help patients with myelodysplastic syndrome in conjunction with azacytidene(Vidaza). CELG is a big player in the MDS area with both Reviled and Vidaza(the latter still has patent exclusivity in EU through 2018, although now generic in US). In addition, CELG also has under development CC-486, an oral version of vidaza, which is felt to be more effective. Pracinostat was felt to be very promising and likely the lead candidate for MDS, and having it knocked out of the box, shifts leadership back to CELG. I would also note that CELG is attacking the most prominent symtom of MDS, anemia, by exercising its collaboration option with XLRN to develop luspaterecpt and sotatercept, the data for which looked most exciting based on data presented at ASH 2014. MDS could easily be 1Bil market for CELG
I suspect it had to do with either low $ offered by Takeda, or conflict with one of the many other collaborators already under SGEN's umbrella
VRTX down 6% today since apparently data did not live up to expectations