Phase 2 extension of a Novartis phase 1/2 trial against NSCLC in salvage mode:
The most common AEs (regardless of causality) were hypoalbuminemia (29%), peripheral edema (27%), and decreased appetite (23%). The most common Grade 3/4 AE (regardless of causality) was increased amylase (7%). Partial responses (PRs) were seen in 12/65 evaluable pts (ORR 18%) and 40/65 (62%) pts had stable disease (SD); disease control rate [PR + SD] 80%. 10/53 pts with IHC 3+ or IHC 2+ and GCN ≥ 5 had PRs (ORR 19%) and 7/23 pts with GCN ≥ 6 had PRs (ORR 30%). Conclusions: INC280 400 mg BID + gefitinib is well-tolerated and shows encouraging clinical activity in EGFR TKI-resistant NSCLC pts, particularly in pts with high cMET GCN. Clinical trial information: NCT01610336
This would usually be considered good enough to justify further study (depending on their internal evaluation of the patient group, possibly enough to generate some urgency). If I recall right,
Novartis's schedule looks forward to introduction of this entity as a drug 2019 or 2020.
Verstovsek et al report in conjunction with (but not at) ASCO (I found the abstract on the ASCO site) on 45 MD Anderson patients treated for MF with Jakafi outside of studies. Here are the key results:
Eighteen of 35 pts with palpable splenomegaly (53%) had a reduction in spleen size by ≥ 50% (complete resolution in 11pts (32%)). Median time to best spleen response was 3 months (0.4-23.6). Improvement in quality of life, including fatigue, weight gain, resolution of fever and night sweats was noted in 19 pts (42%). Seven pts became transfusion dependent after starting ruxolitinib; 1 had an improvement in hemoglobin. At the time of analysis, 18 pts (40%) remained on therapy. 5 pts (20%) discontinued therapy due to anemia/thrombocytopenia. 10 pts transformed to AML with median time to transformation of 9.8 months (3.6-30.1). Nineteen pts (42%) have died; median overall survival was 23.7 months (3.2-36.5).
Because this was a specialty center, the patients may be presumed to be sicker than is typical, but to have been given better than typical treatment. It never entirely balances out. This is a cross-section rather than a formal study; its greatest significance is that it appears to be the first such cross-section published.
These results are good, but clearly leave room for improvement.
I have attended (and presented at) poster sessions. The posters are mounted side-by-side (plenty of space between) on a backdrop. No booth. Generally, one author stands by the poster and talks to anyone interested. I've seen as many as 3 authors around a poster (that tends to happen with first-time authors). (unattended posters happen too)
ASCO is a bit unusual in allowing presentations of experimental designs, before there are any results. It seems likely that this poster was reserved with a design-only abstract against the possibility that there might be interesting early results.
Obviously, the design isn't going to answer any important questions (clinicaltrials entries leave out details of interest to people in the field, so the posters let the people who care get fill-in). Until news gets out (photo, anyone?) we won't know whether the poster shows anything beyond the design.
TMF UltraLong has a generally favorable article out on Incyte. If only it showed some signs of intelligence behind it.
He points to Jakafi sales growth as a recent boost with no attempt to analyze underlying reasons...which are the ONLY reason to pay attention to it (basically: Incyte is priced at a multiple of estimated maximum product revenues, and roughly the last 2 quarters of growth can't be explained without imputing a larger-than-anticipated market size to Jakafi (or should I say ruxo, because a significant part is still off-label). He simply counts ASCO and EHA presentations without evaluating them. He totally ignores the move of epac into phase 3 (which adequately explains most of INCY's recent gains). Most irritatingly, he repeats the lie that Jakafi does nothing to slow the progression of MPNs (refutation of which, interestingly, is the main theme of the Jakafi presentations at ASCO). AND, of course, he anoints that S,N oligonucleotide drug as the inheritor of the MF market, which he also mistakes for the whole Jakafi market. With like a 15% total response rate and completely unacceptable safety/tolerability in its demonstration study, the oligonucleotide is going to have to do A Lot better in its phase 2 before it can be considered a serious candidate to have any significant market.
There may be surprises, but so far the most enduring result for Incyte looks likely to be the push toward using Jakafi in lower risk cases of MF. This gets into a complex interplay of evidence (The Comforts indicate pretty strongly that earlier treatment helps patients substantially, but they weren't designed for that purpose), medical practice and payer agreement. The addressable market for Jakafi could increase 10-25%, but push-back on reimbursement might easily make the money gain smaller than that.
The Minnesnowta Ethiopian will be speaking. His remarks tend to get press coverage, but it's too early in the formal trial of the drug he likes for it to mean much.
Barron's just addressed this for the whole industry. They see political "cooling-off" and a bit of M&A. Fundamentals are affecting individual stocks, with a chance that anyone's unexpected blockbuster could lift the whole sector. They seem to attribute much 2015 strength to unexpected money in Hep C. [Since (according to me) Hep C pricing is untenable long-term nationally, and the crunch will come through politics, there's "a challenge" waiting down the road]
Up there with the stupidest things you've ever said.
1) Myriad DID used to do cancer drug discovery / development. The business was too different from tests.
2) EndoPredicet IS integral to the mission.
Well, that answers the old question about how Myriad will bring EndoPredict selling into the US.
I actually know more people who have died from over-treatment of cancer than from the cancer itself, so reliable prognostic tests are A Big Deal.
Since the kit platform is a key to Myriad's future, I view the loading of the upcoming instruments with a significant-volume test as more important than earnings from the lead test.
I think the merger CC was the first presentation of the commerce model underlying the kit tests. Interpretation will be kept centralized as essentially a web service.
Nice thing I see is that the programs being supported look very much like the classic "investigator-sponsored phase 2s." Single-center, with the theoreticians right there in the clinic. More flexibility in revising protocol than in the usual corporate phase 2. Downside is that results need to be confirmed by a more formal trial before you're confident enough to bet $8 figures.