Roche has chalked up another big success for its new immuno-oncology drug Tecentriq, showing a survival benefit in a phase III trial in non-small cell lung cancer (NSCLC).
The OAK trial revealed that PD-L1 inhibitor Tecentriq (atezolizumab) improved overall survival compared to docetaxel when used as a second-line therapy for NSCLC after platinum-based chemotherapy. Crucially, the drug had a benefit regardless of whether patients’ tumours tested positive for PD-L1.
Roche has already filed for approval of the checkpoint inhibitor in NSCLC, and the FDA is due to deliver a verdict on the dossier in October having already awarded the drug breakthrough status. Tecentriq was recently approved by the FDA in its first indication – bladder cancer – and has already started to make headway in the market.
The positive result could give Roche a chance to catch its rivals in the checkpoint inhibitor category – Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck & Co’s Keytruda (pembrolizumab) – which are already approved for NSCLC and other cancers such as melanoma.
The oncology community is still reeling from the news that – after a string of spectacular successes in clinical trials – Opdivo failed the Checkmate-026 study as a first-line treatment for NSCLC, a result attributed to a desire to cast the patient recruitment net a little too wide.
Opdivo has been dominant in the second-line setting however thanks to the same strategy of enrolling patients regardless of PD-L1 status, whereas Merck zeroed in on patients who had higher levels of expression of the biomarker.
That resulted in a broader label for Opdivo, that could be matched by Tecentriq if the FDA approves the NSCLC indication based on the OAK population and give it a chance to compete head-to-head with Opdivo in the second-line setting.
The first-line market is shaping up quite differently. With Merck able to show a first-line benefit with its PD-L1-targeting approach in the Keynote-024 trial, it is now expected to benefit from a lead of as much as 18 months before it will have a challenger.
Roche has a phase III trial ongoing in PD-L1-selected patients which is due to generate results in 2018, along with a series of trials looking at Tecentriq plus chemotherapy in unselected NSCLC patients.
Meanwhile, BMS is now banking on a combination trial of Opdivo and its CTLA4 inhibitor Yervoy (ipilimumab) that it hopes will support their use as an all-comer therapy, regardless of PD-L1 status.
Of course, with PD-L1 testing becoming more common in the first-line setting there should be a pull-through effect for Keytruda into second-line treatment as well, lessening the advantage of Opdivo’s – and possibly Tecentriq’s – broader label claim.
Regardless, Roche is now poised to go head-to-head against its rivals in the marketplace, backed by its marketing muscle as a long-standing oncology player, according to analyst Tim Anderson at Bernstein.
He has raised his forecasts for Tecentriq on the strength of the OAK data, saying it could make $4.9bn in 2021 if it gets approval for NSCLC as well as colon cancer, behind Opdivo ($8.1bn) and Keytruda (6.5bn) but ahead of AstraZeneca’s PD-L1 inhibitor durvalumab ($1.8bn).