"As so much work has been conducted comparing, combining, and sequencing Cabo w/ erlotinib - how do you see rociletinib introduction impacting Cabo potential in NSCLC?"
Tarceva is still approved for use in EGFR negative 2nd and 3rd line patients. I don't think (haven't really looked hard) that Rocel has been tested in an EGFR negative setting yet so that may still leave a window of opportunity.
"...much like Roceletinib is about to render Tarceva irrelevant."
As so much work has been conducted comparing, combining, and sequencing Cabo w/ erlotinib - how do you see rociletinib introduction impacting Cabo potential in NSCLC? Resistance to EGFRi is well-documented - I'm still assuming there'll remain a refractory treatment slot somewhere downstream for Cabo. You share this sentiment?
Cabozantinib (Cabo) in progressive medullary thyroid cancer.
PATIENTS AND METHODS:
We conducted a double-blind, phase III trial comparing cabo with placebo in 330 patients with documented radiographic progression of metastatic MTC. Patients were randomly assigned (2:1) to cabo (140 mg per day) or placebo. The primary end point was progression-free survival (PFS).
The estimated median PFS was 11.2 months for cabo versus 4.0 months for placebo (hazard ratio, 0.28; 95% CI, 0.19 to 0.40; P less than .001). Prolonged PFS with cabo was observed across all subgroups including by age, prior TKI treatment, and RET mutation status (hereditary or sporadic). Response rate was 28% for cabo and 0% for placebo; responses were seen regardless of RET mutation status. Kaplan-Meier estimates of patients alive and progression-free at 1 year are 47.3% for cabo and 7.2% for placebo. Common cabo-associated adverse events included diarrhea, palmar-plantar erythrodysesthesia, decreased weight and appetite, nausea, and fatigue and resulted in dose reductions in 79% and holds in 65% of patients. Adverse events led to treatment discontinuation in 16% of cabo-treated patients and in 8% of placebo-treated patients.
Cabo (140 mg per day) achieved a statistically significant improvement of PFS in patients with progressive metastatic MTC and represents an important new treatment option for patients with this rare disease. This Cabozantinib (Cabo) in progressive medullary thyroid cancer. This dose of cabo was associated with significant but manageable toxicity
Finding biomarkers for cabo is the right path, but time is not on the side of EXEL due to lousy mgt finacial risk mitigation. Just hoping that meteor read out is favorable and then we get approval for cobi in August. At that point, we can raise more capital (dilutive again unfortunately) and look at the best options. If I can recover my losses and even eak out some gains, I will probably gradually rotate out of EXEl after 8 years holding and building shares. there are better managed companies with better pipelines out there.
Sentiment: Strong Buy
The cycle starts again. Nothing you can do about. Have patience and pick some more up when you think it's low enough. Hold on to your shares! GL
I believe SHORTS are driving SP down in the mornings, on low volume, then covering on the way up. I'm sure there is a word for this "tactic" but whatever it is, to me it SUX!!!! Watch the trading & see if you agree with me. Hopefully it will cease by May 29. JMHO.
Sentiment: Strong Buy
Genentech has been hiring a lot of corporate planning types. They have several more related positions open. One is for a real estate asset manager - South San Francisco. They are also hiring another patent counsel agent. This person must have experience in external relationships with outside counsel and collaborators. This goes beyond agreement support and research collaborations involving just licensing agreements.
There's evidence that sequencing distinct TKIs will provide additional benefits in several cancer types so I don't think Eisai will just give up on Lenvatinib. Their combo w/ Everolimus might just be there to make it not seem like such an also-ran should Cabo's numbers be very good.
I also don't think Everolimus will be squeezed out of the market because of its distinct mTOR inhibition mechanism. I think it's just used because acceptance as second-line treatment and its modest PFS benefit makes it an attractive comparison agent to just get one's foot in the door. I think ultimately the TKIs will be compared against each other, and although the results against Everolimus give some clue about relative efficacy, the trials comparing the TKIs will establish which ones get a priority crack at the disease.
I suppose that this might rule out Eisai as a possible acquirer of EXEL, or they might just decide(based on strong METEOR results) that Afinitor will be squeezed out of the mRCC market, and they better get on EXEL or else their leadership position in mRCC will be threatened. A $2Bil investment in EXEL (assuming METEOR success) would be a wise move on their part and would strengthen their partnership with Roche.
Sentiment: Strong Buy
It looks like trial design as the TKI options in mRCC get more stacked needs to differentiate itself from competition. A monotherapy Lenvatinib vs Everolimus trial would be at best similar to the other TKI options out there and might very well pale in comparison with Cabozantinib so they had to dial it up to 11 and elect for a combo arm to achieve distinguishable results. I'm guessing the toxicities are worse than the Lenvatinib only arm as a result and other TKIs might achieve even better results in combo with Everolimus.
"Are you invested in HALO?"
No, I looked at it and I have to say it looks pretty good, lots of irons in the fire and you have to like a company that wants to cure cellulite. I've introduced a new metric into my due diligence process. All three of my most recent investments are in drug companies that have breakthrough status for one or more drugs. Before granting the designation, FDA gets a look under the hood that we as retail investors do not get to see. It gives me confidence that there is less likelihood of an ugly surprise down the road. It also means that FDA is somewhat invested (figuratively) in the success or failure of a particular candidate.
Lenvatinib is in direct competition for the thyroid cancer indication with cabo and everolimus is the comparator in the METEOR trial. If METEOR results are as good as we're being lead to believe that combo would be meaningless, but what do I know, after all, I own EXEL. LOL
Sentiment: Strong Buy
ulingt. FWIW …MS degrees are often given as a terminal degree to graduate students who don't make the cut off to on onto a PhD track and lastly don't confuse NY Medical College with NY Medical Center (NYU) .
Bug.....I see your medication is not effective.....may I suggest doubling or even tripling your dosage? Be sure to consult with your psychiatrist first! Oh yeah....take Conrad with you. Have a wonderful day and an even better tomorrow!