3 Things In Biotech, April 17: Lung Cancer Madness

Includes: BMY, MRK, RHHBF
by: Zach Hartman

Bristol-Myers shores up against the breaker.

Merck lays the groundwork for domination in first-line lung.

Roche provides first evidence of strong efficacy in mutation-driven lung cancers.

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Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Today, we'll be taking some time to focus on the big recent news coming out of the Annual Meeting of the American Association for Cancer Research (AACR).

Bristol-Myers shores up against the breaker

Company: Bristol-Myers Squibb (NYSE:BMY)

Therapy: Nivolumab and ipilimumab

Disease: Non-small cell lung cancer

News: BMY formally presented the first findings of CheckMate-227, a phase 3 study looking at the combination of nivolumab and ipilimumab compared with chemotherapy for first-line treatment of metastatic non-small cell lung cancer. The study's endpoint has not matured in the overall population, but in the cohort of patients with high tumor mutational burden experienced significant improvement in progression-free survival. These findings were published simultaneously in the New England Journal.

Looking forward: Despite the positive findings from these data, the AACR news hit BMY hard, almost entirely because of the seemingly much better data from Merck (see below). But as Dr. Naiyer Rizvi stated, it is an important finding that we can identify a subset of patients who are amenable to a chemotherapy-free regimen, so it would appear as though BMY has finally found an effective first-line treatment regimen, at least in certain patients.

I think the news of BMY's downturn are premature.

Merck lays the groundwork for domination in first-line lung

Company: Merck (NYSE:MRK)

Therapy: Pembrolizumab

Disease: Non-small cell lung cancer

News: MRK presented the first data of KEYNOTE-189, a phase III study comparing the chemotherapy alone to pembrolizumab-chemotherapy, in a confirmatory trial from the previous KEYNOTE-021 cohort G. In large part, the study results have been confirmed, with patients demonstrating a significant improvement in progression-free survival and the 12-month overall survival rate, all with manageable tolerability. These data were also published in the New England Journal alongside the presentation.

Looking forward: Here would seem to be the coup de grace for BMY's chances in the first line, and they were strong confirmation of what has been suggested by KEYNOTE-021 cohort G, dispelling many of the notion that the benefit of combining pembrolizumab and chemotherapy was a fluke. Now it would seem clear, at least in patients with nonsquamous disease, that there is a lot of benefit to gain. So now, there is soon to be an embarrassment of riches in first-line lung, since patients will soon have access to immune checkpoint monotherapy and various combinations. I expect we'll hear of full approval for pembro-chemo soon enough.

One of the final nails in the coffin for suspicion of chemo-pembro combinations, and now a new journey begins for optimal treatment decisions.

Roche provides first evidence of strong efficacy in mutation-driven lung cancers

Company: Roche (OTCQX:RHHBF)

Therapy: Atezolizumab

Disease: Non-small cell lung cancer

News: RHHBF presented updated findings from the IMpower150 study, particularly in key subgroups of patients, including those with varying PD-L1 expression cutoffs, liver metastases, and presence of mutational drivers. Addition of atezolizumab to bevacizumab-chemotherapy improved outcomes regardless of PD-L1 expression or the presence of liver metastases. However, most interestingly, even patients with EGFR and ALK-positive disease saw signs of a progression-free survival benefit.

Looking forward: The hits from IMpower150 just keep coming for RHHBF. As highlighted by Justin Gainor in the discussion afterward, most studies involving immune checkpoint inhibitors now exclude patients with EGFR/ALK aberrations. And in general, these are not assumed to provide any benefit, thanks to earlier observations. This opens the door for further exploration of combinations involving immune checkpoint inhibitors for mutation-driven lung cancer, which could end up making a very big difference in the treatment algorithm.

Overall, it was the understated news of a really big day that atezolizumab might be effective in these subgroups.

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