Just a week after Roche’s Tecentriq became the first immuno-oncology agent the FDA approved for triple-negative breast cancer, the anti-PD-L1 drug has clinched another first-in-class approval—this time in lung cancer.
The Swiss drugmaker said on Tuesday that the FDA had greenlighted Tecentriq in combination with chemotherapy for treatment of previously untreated extensive-stage small cell lung cancer (ES-SCLC), making it the first cancer immunotherapy in the setting and the first FDA-approved option for the disease in more than 20 years.
SCLC is a smaller market compared with non-small cell lung cancer, accounting for about 10% to 15% of all lung cancers, according to the American Cancer Society. Nevertheless, Baader Helvea analysts previously predicted that the indication could add $1.5 billion to Tecentriq’s sales.
Combinations of chemo drugs, such as carboplatin and etoposide, have traditionally been used to treat SCLC. In the phase 3 IMpower133 study, Roche showed that adding Tecentriq to that chemo pair could extend patients’ lives by 12.3 months, versus 10.3 months for solo chemo. That benefit represented a 30% reduction in the risk of patients' death, and the Tecentriq cocktail cut the risk of disease worsening or death, too.
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First-line SCLC represents the latest addition to Tecentriq’s label. Last year, a regimen combining Tecentriq, Avastin and chemo nabbed an FDA go-ahead as an initial treatment for non-squamous NSCLC patients with no EGFR or ALK mutations. That approval gave Roche a chance to compete with Merck & Co.’s PD-1/L1 king Keytruda in the lucrative front-line lung cancer market. And just a few days ago, the FDA approved Tecentriq, in tandem with Celgene chemo Abraxane, as the first I-O agent for patients with triple-negative breast cancer.
In SCLC, Tecentriq could enjoy the market to itself for a little while, but probably not for long. Merck is studying Keytruda on top of chemo in the phase 3 Keynote-604 trial. Keytruda already boasts an FDA priority review as monotherapy for patients with advanced SCLC whose disease has progressed after two or more lines of therapy, and it expects a decision by June 17. According to data from the phase 2 Keynote-158 study, 35.7% patients with tumors expressing PD-L1 responded to Keytruda, but that benefit was nearly nonexistent in PD-L1-negative patients.
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AstraZeneca is also testing its PD-L1 inhibitor Imfinzi in first-line ES-SCLC in the phase 3 Caspian study. Patients in that study are divided into three groups to receive standard-of-care chemo, Imfinzi plus chemo, or a regimen that adds AZ’s investigational CTLA4 inhibitor tremelimumab to Imfinzi and chemo. The Imfinzi-tremelimumab combo took center stage last year in the high-profile Mystic trial failure in metastatic non-small cell lung cancer.
Bristol-Myers Squibb’s Opdivo was the first I-O agent to enter the SCLC field, thanks to an FDA accelerated approval doled out last October in patients who have undergone at least two prior lines of therapy. However, in the phase 3 CheckMate-331 trial, Opdivo monotherapy failed to extend the lives of SCLC patients who had relapsed on platinum-based chemo. To make things worse for Bristol-Myers, a combination of Opdivo and fellow BMS checkpoint inhibitor Yervoy also failed to beat chemo in the exact same setting in the CheckMate-451 trial.