- For the first time in decades, the Food and Drug Administration approved a new initial treatment for extensive-stage small cell lung cancer, clearing on Monday Roche's immunotherapy Tecentriq for the aggressive tumor type.
- Approval in small cell lung cancer follows an OK for Tecentriq earlier this month in triple negative breast cancer, another first for the rapidly expanding immunotherapy field.
- The decision, which was supported by Roche's IMpower-133 study, hands the Swiss pharma a rare first-mover advantage in lung cancer, a market led by immunotherapy rival Merck & Co. An advantage, however, may be only temporary: A Phase 3 study of Merck's Keytruda was recently marked completed on a federal database of clinical trials.
Bristol-Myers Squibb's Opdivo (nivolumab) was the first immunotherapy approved in small-cell lung cancer, winning an accelerated approval for third-line or later treatment last August.
In the months following that OK, however, the pharma reported successive setbacks in two Phase 3 studies testing Opdivo in earlier lines of therapy for the cancer type. In each trial, Opdivo failed to improve overall survival over comparator, setting back the drug's prospects.
Roche's IMpower-133 study, by contrast, showed adding Tecentriq to chemotherapy improved overall survival by about two months compared to chemotherapy alone — a reduction in risk of 30%.
While that benefit is modest, fewer advances have been made in small cell lung cancer than the much more common non-small cell type. Median overall survival for extensive-stage cases is estimated at only 10 months. Roughly 70% of patients with small cell lung cancer are diagnosed with extensive-stage, according to Roche.
Select immunotherapy trials in small cell lung cancer
|Study drug||Comparator||Treatment line||Current status|
|IMpower-133||Tecentriq||Chemo||1st||PFS, OS hit in June 2018|
|CheckMate-032||Opdivo||N/A||3rd||Led to accelerated approval in Aug. for 3rd line setting|
|CheckMate-331||Opdivo||Chemo||2nd||Missed OS in Oct. 2018|
|CheckMate-451||Opdivo, Opdivo + Yervoy||Placebo||Maintenance after platinum chemo||Missed OS in Nov. 2018|
|KEYNOTE-604||Keytruda||Chemo||1st||Marked completed on clinicaltrials.gov on Feb. 6|
|CASPIAN||Imfinzi + tremelimumab + chemo||Chemo||1st||Primary completion expected by late Sept. 2019|
NOTE: Chemo regimens differ SOURCE: Companies, clinicaltrials.gov
Roche also holds a first-line approval for Tecentriq in non-small cell lung cancer. There, however, it's Merck that holds an advantage, having won several approvals for Keytruda (pembrolizumab) as a monotherapy and combined with chemotherapy.
Tecentriq is also approved for bladder cancer, an indication it shares with several other immunotherapies.
Put together, Tecentriq's first-line approvals in non-small cell and small cell lung cancer, as well as triple-negative breast cancer, could begin to accelerate sales of the drug. Last year, Roche recorded 772 million Swiss francs ($772 million) in Tecentriq sales, up 59% from 2017 but well below the lofty sales earned by Merck's and Bristol-Myers' respective competitors.