Roche said Monday that the first interim analysis of the Phase III IMpower133 trial showed that the combination of its PD-L1 inhibitor Tecentriq (atezolizumab) plus standard chemotherapy met the co-primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment in patients with extensive-stage small-cell lung cancer (ES-SCLC). Sandra Horning, Roche's chief medical officer and head of global product development, remarked "the clinically meaningful results from the IMpower133 study add to the growing body of evidence demonstrating that Tecentriq-based combinations may be an effective treatment for different types of advanced lung cancer."
In the study, 403 chemotherapy-naïve patients with ES-SCLC were randomly assigned to treatment with Tecentriq or placebo, both in combination with carboplatin and etoposide, with treatment continuing until disease progression or symptomatic deterioration was observed. Both OS and PFS were examined in the intent-to-treat population.
Roche noted that the safety profile of the combination regimen "appeared consistent with the known safety profile of the individual medicines," while no new safety signals were observed. The drugmaker added that the IMpower133 results will be presented at an upcoming research conference.
Commenting on the news, Baader Helvea analysts stated that gaining a "first mover advantage" in this indication could add $1.5 billion to Tecentriq revenue. Baader Helvea analyst Bruno Bulic remarked "we see Tecentriq gaining momentum in lung cancer."
Roche noted that this is the fourth late-stage study to report positive data for a Tecentriq-based combination in lung cancer this year. Last month, the drugmaker unveiled data from the Phase III IMpower130 trial illustrating that the PD-L1 inhibitor prolonged OS and PFS in patients with advanced non-squamous non-small-cell lung cancer (NSCLC). The company also released updated results detailing survival data from the Phase III IMpower150 study of Tecentriq in combination with Avastin (bevacizumab) and chemotherapy in the first-line treatment of advanced non-squamous NSCLC.
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