Coming fast on the heels of Bristol-Myers Squibb’s stinging setback with its star cancer therapy Opdivo, Roche says that its PD-L1 checkpoint drug Tecentriq (atezolizumab) hit its key goals in a Phase III study for non-small cell lung cancer, extending the lives of patients in the trial.
The pharma giant’s big Genentech unit reported that Tecentriq met its co-primary endpoints on improving survival rates for the overall population of lung cancer patients as well as a specific subgroup selected by PD-L1 expression, a crucial biomarker for this treatment. Investigators gathered the data among 1,225 patients whose lung cancer had spread on or after chemo.
The pharma giant was sticking with top-line data online in this first analysis, holding back the specific results for an upcoming scientific conference — standard practice in R&D, at least for positive studies. And Roche says it plans to hustle the new data to the FDA as it works intently on growing the market.
The success lands just weeks after Bristol-Myers managed to stun just about everyone in the oncology field with the news that its Phase III for its PD-1 drug Opdivo in first-line lung cancer patients had failed, instantly giving Merck a big edge in a huge market. Opdivo’s failure startled a big crowd of investors who had become used to considering Opdivo as the dominant player, disrupting a field that is delivering megablockbuster returns.
Roche has been playing catch-up with Bristol-Myers — the dominant player — and Merck. But it has attracted considerable attention for its complementary PD-L1 approach, which is carving out its own place in the market after gaining its first approval for bladder cancer back in May.
Bristol-Myers’ setback in the checkpoint field — where drugs dismantle a mechanism that hides cancer cells from an immune system attack — spurred some significant criticism that the company had tried to tackle a patient population too big to deliver positive results, forcing investigators to rethink how they design and execute Phase III studies for a checkpoint program. Researchers on the Bristol-Myers study had recruited a broad population of 541 previously untreated first line patients whose tumors expressed PD-L1 at a low level of ≥ 5%.
Genentech, meanwhile, has eight late-stage studies ongoing for various stages of lung cancer, highlighting its significance in a booming field. And with breakthrough status at the FDA, it expects to hustle up a whole slate of applications to expand its use.
Seamus Fernandez at Leerink sees tougher headwinds ahead for Opdivo now:
At a minimum, we have to assume that this result will increase the view that PD-1 & PD-L1 antibodies have very similar efficacy profiles, resulting in increased competition in 2L lung cancer – Opdivo’s current stronghold. In our view, this places even greater importance on a positive outcome in the CheckMate-227 (CM-227) trial of Opdivo + Yervoy (ipilimumab; CTLA-4 inhibitor) in 1L NSCLC. While full results of the OAK trial will determine if physicians will distinguish Tecentriq commercially, we believe the top line results suggest less efficacy differentiation between Tecentriq, Opdivo, and Merck’s (MP) Keytruda (pembrolizumab; PD-1 inhibitor), and near-term, MRK is likely to maintain the most unique opportunity in 1st line NSCLC.
Sandra Horning, Roche’s chief medical officer and head of Global Product Development, had this to say:
“These results add to the growing body of evidence that supports the role of Tecentriq as a potential new treatment for specific types of advanced NSCLC. This is very encouraging news for people living with this disease because lung cancer is the leading cause of cancer deaths around the world. We hope to bring this treatment option to patients as soon as possible.”
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