Roche's Tecentriq secures another immunotherapy first – BioPharma Dive

Posted by on March 20, 2019 6:52 pm
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Source: Roche's Tecentriq secures another immunotherapy first – BioPharma Dive

Dive Brief:

  • 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.

Dive Insight:

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.

Published at Tue, 19 Mar 2019 15:50:34 +0000

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