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2018-12-24| Trials & Approvals

Tecentriq bags yet another FDA approval, this time as a combo therapy for NSCLC

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

Following positive results in a phase III trial, the drug registers its fourth FDA approval in the past two years.

 

Background and History

Tecentriq (Atezolizumab) is a humanized, monoclonal antibody engineered against PD-L1 protein that suppresses the immune system. It blocks the interactions of PD-L1 with PD-1 receptor, thereby enabling the activation of T cells. Developed in 2015 by Genentech/Roche as an investigational immunotherapy candidate, it soon excelled in various trials as combination partner with various immuno- and chemotherapies. As a consequence, it received priority reviews and eventually garnered FDA approvals for the treatment of various cancers including advanced bladder cancer, urothelial carcinoma and a specific type of metastatic lung cancer.

Approval for NSCLC

On December 7th, Roche announced its FDA approval as a combination therapy for the first line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This incorporates Tecentriq with another standard cancer therapy combo involving Avastin (Bevacizumab), paclitaxel and carboplatin (chemotherapy), which was approved way back in 2006 for the treatment of NSCLC.

Roche’s Chief Medical Officer, Sandra Horning, MD expressed her views on the approval. “This Tecentriq regimen has demonstrated a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer,” she said. “Today’s approval supports our combination approach for Tecentriq in lung cancer and our vision to develop medicines that improve outcomes for patients with this complex disease.”

 

Phase III IMpower150 Study

This approval is an outcome of a successful multicenter, open-label, randomized, controlled phase III IMpower150 study that evaluated Tecentriq in combination with Avastin and chemotherapy in treating stage IV or recurrent metastatic NSCLC. Around 1,202 people were enrolled in the study, out of which 1,045 were in the intention-to-treat wild-type (ITT-WT) subpopulation that excluded patients carrying mutations in EGFR or ALK. It was observed that people who received this combination lived significantly longer with a median overall survival [OS] of 19.2 months as compared to the 14.7 months with Avastin and chemotherapy only (hazard ratio [HR]=0.78; 95%, CI: 0.64–0.96; p=0.016). The combination therapy also reduced risk of disease by 29% and the overall response rate [ORR] was 55% of people as compared to 42% with Avastin and chemotherapy only. The safety profile of the combination was found to be consistent with that of previous studies.

 

Competition

Still, Tecentriq lags behind and would face stiff competition from Merck & Co.’s anti-PD-1 therapy, Keytruda (Pembrolizumab) which in combination with Eli Lilly’s Alimta (Pemetrexed) and carboplatin was approved by the FDA in May 2017 as first-line treatment of metastatic non-squamous NSCLC. Another potential candidate that might enter this market is Bristol-Myers Squibb’s Opdivo (Nivolumab).

 

References
  1. https://www.roche.com/media/releases/med-cor-2018-12-07.htm
  2. https://www.biopharmadive.com/news/roches-tecentriq-gets-first-line-lung-cancer-approval/543869/
  3. https://www.nejm.org/doi/full/10.1056/NEJMoa1716948
  4. http://www.ascopost.com/News/55616

 

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