To recap, Novartis' (then GSK's) combo was approved conditionally on P2 data in the US but not in the EU, and there was a piece about them seeking full approval with more mature Combi-D and V data now. I expect Roche to preempt them in the EU since they finished their P3 and filed first in the EU.
I meant not placebo but control arm:
There was also a survival benefit to subset of patients who had prior Cabazitaxel. In the whole experimental population, the placebo arm showed far more patients who went onto subsequent Cabaz. than in the control arm. My guess is that it was fairly obvious they were getting prednisone from the AE profile and enterprising patients would have quickly sought a further line.
Sometimes they're the whistle-blower that uncovers a scam and reduces the scope and duration of harm. People too engaged with just the positive aspects of things get led off of cliffs with their life savings.
The CEO has mentioned repeatedly the possibility of registration based on PII for IMGN853 and Pazdur has specifically mentioned the need for treatments in ovarian cancer. I'd say that makes the Phase I news very exciting. The Phase I data is still developing so any additional data and the details of a Phase II initiation will be a catalyst. There will be news from GATSBY, news from BT-062, news from IMGN529, SAR3419, and IMGN779. There's certainly a risk any of these programs could fail but the substantial interest from big pharma, the new linker technology used in some of these adcs and the low associated toxicity (mostly grades 1 & 2 for 853) seems quite different from prior reports from say IMGN901 (which had grades 3 & 4 toxicities). I'd say the impression of IMGN technology that Adam F. gave is mostly sensational (sells him clicks) and largely inaccurate, but I see a good chance that stock reaching market cap parity w/ SGEN in the long run (that might mean SGEN craters btw).
I think a docetaxel control arm would make sense and have a fair chance at success. A PD-1 inhibitor control arm would also make sense but it be a much tougher trial.
They sold closer to 29mm shares instead of the projected 20mm or 25mm revised figure which sounds like a broad show of interest. (Either that or Ernie has deeper pockets than I thought.)
Obviously he's not talking about taxanes and directly referring to unapproved pipeline agents of a different class like Mirvetuximab Soravtansine in this article when he says "chemotherapy."
The combo is not especially well tolerated, note the 2 grade 5 AEs:
All patients experienced at least one treatment-emergent adverse event (AE) across all treatment arms. Treatment-related grade 3 AEs occurred in 71% of patients in the combination arm, 83% in the single-agent lenvatinib arm, and 52% in the everolimus arm. “Notably, there was a 20% incidence for grade 3 diarrhea in the combination arm, which highlights the need for recognition and management of this toxicity for the combination, in particular,” said Motzer. There were relatively few grade 4 events in any of the three arms. Two grade 5 AEs were attributed to lenvatinib. Lenvatinib dose reductions were required for 71% of patients in the combination arm compared with 62% in lenvatinib alone arm. Of those in the everolimus monotherapy arm, 26% required a dose reduction. "Further study of lenvatinib therapy is warranted in RCC," Motzer concluded.
It's a small indication, and if you look at the EXEL side of the story, it just doesn't have any other choice for a source of cash flow. A quick look at Genzyme show sit has Thyrogen which detects thyroid cancer so it's possible they see value in building out their thyroid cancer franchise.
Proceeds for global rights were $165mm upfront + $135mm of sales milestones. The only other indication besides MTC where it is in late trials is DTC which is in Phase 3 (NCT01876784).
Fair point. Pricing wouldn't be as strong if it were based today's movement. I imagine interested parties have asked to be allocated by now though.
Actually, they were lucky to raise money before BIIB earnings brought down biotech. If Scangos told them, we should be thanking him!
I should say bad guidance for Tecfedera and their all other drugs too. Gotta be careful w/ these companies George Scangos runs... :)
Today's story is all Biogen. Bad earnings + unfavorable Alzheimer's data earlier this week sees share prices dropping by a fifth. Could be the basis for a correction.
A partnership to fund a EGFR wt NSCLC study next year (instead of waiting for sufficient cash flow as an independent company) would add two years of NSCLC revenues before patent expiry which could amount to a discounted value of a couple hundred million.
They could run probably independently run trials in DTC, RET fusion NSCLC as well as MET related NSCLC indications, but they could always use help in bringing online earlier some of those potential streams.