Merck’s Keytruda already has the immuno-oncology lead in non-small cell lung cancer, and it’s making sure it stays that way. On Monday, it rolled out new monotherapy data that could significantly expand its patient pool.
In a closely watched trial, the blockbuster topped chemo at improving overall survival among first-line patients with the disease. And that benefit extended across PD-L1-positive patients in the study, regardless of their level of PD-L1 expression.
The results follow an approval from late 2016 that cemented Keytruda’s place at the top of the I-O heap. NSCLC is the most lucrative market for the new therapies, and Keytruda was the first—and still is the only—PD-1/PD-L1 drug to win a monotherapy approval in the first-line space. That nod was for patients with PD-L1 levels of 50% or higher, though, meaning the new data could extend to many more patients; about 70% of all first-line patients are PD-L1 expressers, Bernstein analyst Tim Anderson wrote to clients.
With the top-line data, Keytruda will displace chemotherapy “as the reference for the majority of patients,” Anderson noted. The results “change the way patients, physicians and payers” will value each of the approaches in development, ranging from monotherapies to chemo combos to CTLA4 combos.
“Where the data for the combination options overlap with Keytruda, the incremental gain and incremental cost will be measured relative to it—not chemotherapy,” Anderson wrote.
And that leaves less room for rivals such as Bristol-Myers Squibb, which is readying a tandem approach in the wake of a monotherapy failure.
“Already it is conceded that Keytruda is the best option for the PD-L1-high expressing patients given its combination of tolerability and efficacy, even though chemo-combo also shows high efficacy in the same segment. Will the same come to be said for 70% of 1L NSCLC?” Anderson wrote.
Investors will have to wait and see, with expanded Keytruda data expected to drop at a future medical meeting. In the meantime, all eyes are still on late-stage regimens from BMS, Roche and AstraZeneca that could shape the future of the field—and investors will have to forget whatever they thought they knew about how the market-share battle would play out.
“If anything is certain about immuno-oncology, it is that nothing is certain,” Anderson wrote, adding that “the division of the 1L NSCLC market between manufacturers and approaches … that tempted investors based on 2018 news flow to date was up-ended this morning.”