Top-line results from a phase III trial of Roche’s PD-L1 inhibitor Tecentriq have shown the drug cuts progression-free survival in first-line non-small cell lung cancer (NSCLC).
The new data could give Roche the ammunition it needs to take on Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab), which currently dominates the first-line NSCLC category after arch-rival Opdivo (nivolumab) from Bristol-Myers Squibb failed its own clinical test in previously-untreated patients and is the only other cancer immunotherapy with chemo combination approval (in the US).
Merck pulled its EU filing for Keytruda as a first-line treatment for non-squamous NSCLC in combination with carboplatin and Eli Lilly’s Alimta (pemetrexed) last month, saying it wanted to include overall survival as an endpoint in one of the key studies backing the application (KEYNOTE-189) that would set back its completion date to early 2019.
The results of the Impower 50 trial reveal that combining Tecentriq (atezolizumab) with chemotherapy and Roche’s targeted drug Avastin (bevacizumab) improved PFS in non-squamous NSCLC, compared to those treated with Avastin plus chemo alone.
Roche now says it intends to move ahead with regulatory filings based on the data, adding that an early look at overall survival data is also ‘encouraging’ and mature data on that endpoint is due next year.
Nevertheless, third-to-market Tecentriq is a long way behind its two biggest checkpoint inhibitor rivals, which are both well on their way to mega-blockbuster territory with sales of $2.5bn for Keytruda and $3.6bn for Opdivo in the first nine months of the year, spread across multiple indications.
Approval in first-line NSCLC would give Roche an indication with a big patient population and just one key rival as BMS as well as recent market entrant AstraZeneca have both reported disappointing data in the indication. As it stands, Tecentriq is already growing quickly, making CHF 355m ($357m) in the first three 2017 quarters from its use in bladder cancer and second-line NSCLC.
Both of those therapeutic categories are pretty competitive however, with multiple checkpoint inhibitors vying for market share, although Roche was first to get the OK in bladder cancer. It now has an opportunity to gain momentum in NSCLC, according to Evercore ISI analyst Umer Raffat who said: “Roche is now a real competitor in first-line lung cancer.”
He also said the data lends weight to the approach of combining cancer immunotherapies with chemotherapy, rather than pairing immuno-oncology drugs together as has been trialled by BMS and AZ.