The key dates for KRAS watchers through the end of the year — the trail is narrow and risks are extreme
There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.
And it didn’t take much data to do it.
There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too.
Never mind that the drug doesn’t actually have to lose out in a clinical study to be discounted — a significant drop in responses in a bigger group would be enough to disillusion investors. Let’s remember Nektar. But for now, this landscape is being painted with blockbuster numbers to fill in.
This morning Evan Seigerman at Credit Suisse jumped in with this:
We highlight that early data have been encouraging, though we await detail on the registrational trial design, and additional efficacy and durability data across all indications. We project initial approval and use in 3L/2L by 2023, generating sales of >$2.5B by 2030 to which we apply a 40% PoS.
AMG 510 is recognized as the leading G12C drug aimed at a pocket on KRAS that could bring this long-studied target into the range of a drug for the first time. And the pharma giant is doing everything possible to prove that it can execute quickly and effectively in taking it from Phase I to a registration study and on to the FDA. So kudos for grabbing the industry’s attention and keeping it. But it’s very risky at every step.
And everything could change over a matter of months.
Michael Yee at Jefferies wants to see more data and is plugging some dates into his calendar. From earlier in the week:
At World Lung (9/7-9/10) next up – 50-75% ORR is great? The AMG-510 abstract (released 8/21) probably wont be that interesting since submission was likely back in April. We expect the updated lung data in the oral session on 9/8 to show: (1) ~3 additional months of follow-up for the initial 5 of 10 responders (e.g. going from April to perhaps late July cutoff), so treatment duration could extend from 7-27 weeks to 19-39 weeks (e.g. 5-9 months), (2) ORR for high dose coming anywhere from 50-75% but logically it should come down from the perfect 100% (n=3/3) perhaps down to ORR=75% (co not specific how many pts, est but n=10-15 perhaps), (3) no early relapses or drug resistance. Ultimately, we think 4-6 months of duration of response on more patients would be meaningful as 2L chemo has a low response with no durability…
Andrew Berens at SVB Leerink is also checking off dates on the 2019 calendar, with an eye on Mirati’s stock, which faces its own catalyst in Q4.
Mirati’s MRTX849 in 4Q19, potentially at the Triple Meeting in October. While we note recent pressure on MRTX shares following competitor downgrades citing high expectations for the initial ‘849 data, we see the next two catalysts—’510 updated lung cancer data at World Lung (9/7-10) and ‘510 data at ESMO (9/27-10/1)—as likely to be further validating for the class, providing additional evidence of monotherapy durability in non-small cell lung cancer (NSCLC) and bolstering confidence in utility of the class in tumor types beyond lung cancer.
And here’s Yee again on the upside for the two contenders:
Investor excitement over the two leading KRAS drugs (AMGN and MRTX) is likely to continue w/ more data over the next few months. If ALK+ lung drugs are $1-2B as a class yet KRAS is 4x bigger, then it’s theroetically a line of sight on a multi-billion potential opportunity in lung cancer…
Catalyst watching is always fun in biotech. And this one has lots of eager followers. Amgen hasn’t stirred this much excitement in its pipeline for years.
Social image: Amgen, AP Images