- Positive results from a late-stage clinical study of Roche's immunotherapy Tecentriq could hand the Swiss pharma a leading position in the less common small cell form of lung cancer, even as rival Merck & Co. consolidates its advantage in treating non-small cell tumors.
- Tecentriq, when paired with chemo, helped previously untreated patients with extensive-stage small cell lung cancer live longer than those given chemo alone, according to topline results announced Monday. SCLC is estimated to account for roughly 15% of all lung cancers.
- "These are the first positive Phase III survival results for any immunotherapy-based combination in the initial treatment of extensive-stage small cell lung cancer, a particularly difficult-to-treat type of disease," said Roche's Chief Medical Officer Sandra Horning in a statement.
Roche has been here before. In March, the drugmaker announced a combination of Tecentriq (atezolizumab) and chemotherapy had extended progression-free survival in patients with squamous forms of non-small cell lung cancer.
Analysts thought the trial success could give Tecentriq a shot at being first to market, complete with all the attendant advantages in market share that come from launching without competitors.
Merck, however, upstaged Roche soon after, presenting data showing its rival drug Keytruda (pembrolizumab) plus chemotherapy cut the risk of death by 36% over chemo alone in a similar, squamous patient population. Merck has already filed the data with U.S. regulators in hopes of securing an approval. As Roche's study has not yet reported overall survival results, Keytruda looks to have set a competitive bar for Tecentriq to clear.
The story is similar elsewhere in non-small cell lung cancer, where Merck has quickly built a dominant position on the back of impressive data presented at recent medical conferences.
Small cell lung cancer, on the other hand, still appears an open opportunity for the checkpoint inhibitor class. Merck, as well as Bristol-Myers Squibb and AstraZeneca, also have trials underway of their respective immunotherapies in small-cell lung cancer.
Select immunotherapy trials in small cell lung cancer
|Study drug||Comparator||Treatment line||Number of pts.||Status|
|IMpower-133||Tecentriq + EP||Placebo + EP||First||403||Positive results reported in June|
|Keynote-604||Keytruda + EP||Placebo + EP||First||430||Primary completion in Jan. 2019|
|CheckMate-451||Opdivo, Opdivo + Yervoy||Placebo||Maintenance after platinum chemo||940||Primary completion in Sept. 2018|
|CheckMate-331||Opdivo||Topotecan or amrubicin||Second after platinum chemo||568||Primary completion in Aug. 2018|
|Caspian||Imfinzi +/- tremelimumab, + EP||EP||First||984||Readout expected in 2019, w/ submission to follow|
Note: "EP" = etoposide + platinum-based chemotherapy | SOURCE: Companies, clinicaltrials.gov
But Roche looks to be out in front, particularly if a regulatory submission follows quickly on the heels of the data presented Monday. Filings to the Food and Drug Administration and European Medicines Agency are planned.
No detailed results were disclosed, but Roche did note the Tecentriq-based combination hit on both primary endpoint measures of overall survival and progression-free survival.
Bristol-Myers could be next up with immunotherapy data in small-cell lung cancer, yet its studies test Opdivo (nivolumab) outside of the first-line setting. Merck and AstraZeneca both expect data in 2019.
Small cell lung cancer is also the setting of a costly trial disappointment for AbbVie's experimental antibody-drug conjugate Rova-T, acquired in a nearly $10 billion deal for Stemcentrx in 2016. The drug's failure in the third-line setting wiped more than 10% off of the company's stock price and safety risks observed raised serious questions about the drug's risk/benefit profile.
Studies in first- and second-line settings continue, as well as a Phase 1 trial pairing Rova-T with Opdivo and Yervoy (tremelimumab).