Roche's Tecentriq scores solo win in lung cancer. But can it challenge Merck's Keytruda?

Roche, late to the scene in non-small cell lung cancer, has been looking to capture share from Merck with its Tecentriq-chemo combo. And it just got one step closer to bringing its quest to the monotherapy arena, too.

In a phase 3 study, Tecentriq topped chemo at lengthening the lives of previously untreated patients without ALK or EGFR mutations, Roche said Thursday. The pharma giant saw the survival benefit among those with high levels of biomarker PD-L1, and the study will continue to see whether Tecentriq can produce a benefit for patients with lower levels of the protein.

Details of Roche’s win won’t come out until a future medical meeting, but for now, the Swiss drugmaker will be sharing them with health authorities around the world in an effort to “bring this option to patients as quickly as possible,” it said.

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If Roche can grab an approval, Tecentriq will go up against an established player in Merck’s Keytruda, which nabbed its own monotherapy approval nearly three years ago. But the New Jersey drugmaker’s chemo combo is the therapy option that’s stolen the show, thanks to its ability to cut patients’ death risk in half regardless of their levels of PD-L1.

Keytruda monotherapy has still found a place in the market for those who can’t tolerate chemo, but like Roche’s so far, Merck’s data have shown that the solo drug’s greatest utility is among PD-L1-high patients. The fact that data haven’t been “overwhelmingly positive in patients with PD-L1 levels of 1-49% leaves that population potentially more available to better combination therapy approaches in the future,” Credit Suisse analyst Vamil Divan wrote to clients last year.

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In the meantime, Roche is working to chip away at Keytruda’s combo lead with its own cocktail of Tecentriq, chemo and anti-VEGF drug Avastin. Its strategy “looks to be focusing on special populations, namely those with liver metastases and driver mutations,” SVB Leerink analyst Daina Graybosch wrote to clients earlier this week.