FDA, Immuno-oncology

Roche stacks up Tecentriq nods, following up breast cancer approval with small cell lung cancer

Roche is carving itself a tidy niche with Tecentriq in cancer pockets that other immunotherapies haven’t yet conquered. After scoring approval in frontline use for breast cancer last week, the Swiss drugmaker on Tuesday said the checkpoint inhibitor has secured the FDA nod as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).

Tecentriq will be added to chemotherapy — carboplatin and etoposide — as the first new option in more than two decades for treatment-naive patients whose small cell lung cancer has spread, Roche said, adding that the monoclonal antibody is the only cancer immunotherapy to win approval in this difficult-to-treat category of patients.

Lung cancer — which encompasses small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) — causes the highest number of cancer-related fatalities globally, the WHO estimates. SCLC, sometimes called oat cell cancer, account for 10% to 15% of all lung cancers, according to the American Cancer Society.

The Tecentriq approval was based on the Phase III IMpower133 study, the results of which were published last September. Data showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival=12.3 vs. 10.3 months, respectively; p=0.0069), and the Tecentriq combo also significantly reduced the risk of disease worsening or death compared to chemotherapy alone (PFS=5.2 versus 4.3 months, respectively; p=0.017).

In the United States, Tecentriq is already approved as a monotherapy or a combo in other types of lung cancer patients including the initial (first-line) treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations as well as metastatic NSCLC patients whose disease has progressed during or following platinum-containing chemotherapy.

Roche’s Tecentriq still has much to do before it catches up with de facto leaders: Merck’s $MRK Keytruda and Bristol-Myers’ $BMY Opdivo, but its strategy of nabbing indications overlooked or ahead of the others could help establish it as a key player in the increasingly crowded field.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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