Roche's PD-L1 inhibitor Tecentriq has been approved by the US FDA as a second-line therapy for non-small cell lung cancer, putting the new drug in direct opposition to its main immuno-oncology rivals for the first time.
Tecentriq (atezolizumab) was first approved in May for treatment of bladder cancer, an indication not yet targeted by the two PD-1 inhibitors on the market - Merck & Co's Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab).
Now, the three checkpoint inhibitors will battle toe to toe for the much larger NSCLC sector, although Roche will have to work hard to displace Opdivo and Keytruda given their long lead in the lung cancer market.
The Swiss group's strong presence in cancer therapy and strong links with oncologists are however expected to help it catch the leaders, and Bernstein analyst Tim Anderson recently predicted the drug could make almost $5bn in sales in 2021 if it also picks up an approval in colon cancer.
That still keeps Tecentriq in third place behind Opdivo (with predicted 2021 sales of $8.1bn) and Keytruda ($6.5bn) but ahead of AstraZeneca's PD-L1 inhibitor durvalumab ($1.8bn).
The green light comes on the back of the phase III OAK trial which showed that patients treated with Roche's drug lived almost 14 months on average - around four months longer than those on docetaxel - as well as the phase II POPLAR study.
Tecentriq's chances of making a strong showing in NSCLC are helped by a broad label. The FDA has cleared the drug for NSCLC patients whose disease has progressed during or after platinum-containing chemotherapy or a targeted therapy if their tumours have EGFR or ALK mutations.
That gives it an equivalent label claim to Opdivo, which has been dominant in the second-line NSCLC treatment setting thanks to a broader label than Keytruda, which required that patients be tested to see if their tumours express high levels of the PD-L1 protein.
The first-line NSCLC category is however developing very differently. Opdivo stumbled badly in its Checkmate-026 first-line study, while Merck's drug aced its Keynote-024 trial and is now on course for a swift approval. Roche has a phase III trial ongoing in previously-untreated NSCLC patients but this is not due to generate results until 2018.