AstraZeneca’s immunotherapy drug scores key Phase III lung cancer win

In Clinical Studies News by Barbara Jacoby

By: Alaric DeArment

From: medcitynews.com

The company said the Phase III CASPIAN study of Imfinzi in first-line, extensive-stage small-cell lung cancer was successful, but did not disclose further details. Roche’s Tecentriq is already approved for that indication, which accounts for two-thirds of SCLC cases.

The days of Roche having an immunotherapy monopoly on the largest population of small-cell lung cancer patients appear numbered, following the release of data for a competing drug.

London-based AstraZeneca said Thursday that data from its Phase III CASPIAN study showed that the PD-L1 checkpoint inhibitor Imfinzi (durvalumab) combined with platinum-based chemotherapy improved overall survival (OS) in first-line extensive-stage SCLC (ES-SCLC) patients.

The company said the data were statistically significant and clinically meaningful, but did not provide specifics, adding that the results have been submitted for presentation at an upcoming medical meeting. ES-SCLC accounts for about two-thirds of SCLC cases, with SCLC itself accounting for 15 percent of lung cancer cases overall, according to AstraZeneca. The vast majority of lung cancer cases are non-small cell lung cancer (NSCLC).

Shares of AstraZeneca were mostly flat on the New York Stock Exchange following the news.

Assuming the CASPIAN results lead to Food and Drug Administration approval, Imfinzi will compete head-to-head against another PD-L1 checkpoint inhibitor, Roche’s Tecentriq (atezolizumab). Tecentriq is already approved for first-line ES-SCLC in combination with the chemotherapy drugs carboplatin and etoposide.

In the Phase III IMpower133 study, Tecentriq and chemotherapy produced a median OS of 12.3 months, compared with 10.3 months for placebo and chemotherapy, according to the drug’s package insert.

Meanwhile, Merck & Co.’s PD-1 inhibitor, Keytruda (pembrolizumab), won accelerated approval from the Food and Drug Administration last week as a single agent for metastatic SCLC that has progressed on or after platinum-based chemotherapy and at least one prior line of therapy. That drug was already approved for several NSCLC indications. Another PD-1 inhibitor with indications for both SCLC and NSCLC is Bristol-Myers Squibb’s Opdivo (nivolumab), while both Imfinzi and Tecentriq are also approved for certain patients with NSCLC.

The combination of Imfinzi and tremelimumab – itself a potential competitor to BMS’ CTLA-4 inhibitor, Yervoy (ipilimumab) – is also being tested in the Phase III ADRIATIC study among patients with limited-stage SCLC who have not progressed following concurrent chemoradiation therapy. Imfinzi is currently also approved for patients with metastatic or locally advanced urothelial carcinoma who have disease progression after platinum-based chemotherapy treatment.