Wednesday night's big round of ASCO news highlighted a few key memes with major implications for cancer drug development and everyone who works in the field. Overall, there were no big surprises in the news. And that's news in itself. Across the board Bristol-Myers Squibb ($BMY), Merck ($MRK) and Roche ($RHHBY) all demonstrated that they were racing ahead with a broad array of immuno-oncology studies covering a widening sphere of tumors. And AstraZeneca ($AZN) finally got a chance to distinguish itself in a credible way that provides solid evidence that the company is onto at least a couple of programs with blockbuster potential.
By making AstraZeneca look like it's worth more, it may yet elude Pfizer's ($PFE) tightening grip.
The cancer drug development game is changing now. Instead of focusing on which immuno-oncology drugs have the greatest promise, or will get to regulators first, analysts are starting to get some clarity on how each company is doing on particular cancer types, handicapping the race according to who's ahead and who's falling behind as each of these programs jockey for position and new combination approaches in multibillion-dollar markets.
You can also expect to see more Phase I results set the stage for late-stage studies. Investigators and companies have learned how to fast-track these development programs, carving months out of the schedule. Winning fast is the new rule in this field, which now absorbs about 30% of all the industry's early-stage resources. And that could have big implications for huge numbers of patients fighting cancer, and the select group of payers in the U.S. and Europe which can expect to grapple with a new wave of expensive therapies.
Merck, which is leading the charge to the FDA with a melanoma application for MK-3475, didn't have much to show Wednesday night, aside from a 36% overall response rate for a small group of previously untreated PDL-1-positive lung cancer patients. That's quite competitive with what Bristol-Myers has been seeing, according to ISI's Mark Schoenebaum, but it's early days yet.
Roche, meanwhile, noted that MPDL3280a registered a 50% response rate for PDL-1-positive bladder cancers, with 10 of 20 patients in a small study demonstrating a tumor response. Leerink is looking to ASCO for more data on this drug but seems pumped. "Replication of these results likely would warrant both a breakthrough designation along with accelerated approval on the basis of the recently initiated single-arm Ph II study," noted the Leerink group today. Roche is hoping that its early success in bladder cancer will translate into broad efficacy in a range of cancer types.
The one big loser of the evening was poor Eli Lilly ($LLY), which often can't seem to catch a break no matter how hard it tries. After seeing some real success in oncology with ramucirumab, which could finally provide a ticket to blockbuster status, Lilly posted positive but weak results from a Phase III study of necitumumab for first-line squamous lung cancer, reminding many analysts why they discounted this drug to begin with. Lilly needs new approvals any way the company can get them, though, so look for a filing later this year.
Lilly appears to be doing better with CDK4/6 data for breast cancer, but there will be much more scrutiny to come.
Bottom line: Not surprisingly, come the end of the month, ASCO's spotlight will remain fixed on the promise of debugging the human immune system, with an opportunity to significantly extend the lives of cancer patients. That's a game dominated by a short lineup of giants.
In the next two articles (on Bristol-Myers and AstraZeneca), I break out the top stories to come from the ASCO abstracts.
- here's the release from Eli Lilly