The standard of care for small-cell lung cancer (SCLC) had been unchanged for over 20 years, with platinum-based chemotherapy being the treatment of choice for extensive-stage (ES) disease. However, in 2018, the approval of Bristol-Myers Squibb"™s Opdivo (nivolumab) in the second-line setting marked the beginning of the immunotherapy era for ES-SCLC.
Sakis Paliouras, Oncology and Hematology Analyst at GlobalData, comments: "The US Food and Drug Administration (FDA) approved Genentech"™s Tecentriq (atezolizumab) in combination with chemotherapy as a first-line treatment for ES-SCLC based on a 30% reduction in risk of death observed in the Phase III IMpower133 trial. This approval established Tecentriq as the standard of care and transformed the treatment paradigm by including immunotherapy agents in both the first and second line. In June 2019, Merck"™s Keytruda (pembrolizumab) also received FDA approval as single agent for the treatment of patients who had progressed on more than one other lines of therapy, claiming a share of the second-line market."
AstraZeneca"™s Imfinzi (durvalumab) received priority review status by the FDA in November 2019 for the first-line treatment of ES-SCLC in combination with chemotherapy based on data from the Phase III CASPIAN trial showing a 27% reduction in the risk of death. PharmaMar"™s lurbinectedin received priority review in February 2020 for the treatment of patients who progressed on previous platinum therapy based on data from a single-arm, Phase II study showing an overall response rate (ORR) of 35.2%. It is therefore probable that two new branded agents will enter the SCLC market during 2020, eroding away any remaining share from second-line chemotherapy.
Paliouras concludes: "This will bring the number of new, premium-priced agents available in 2020 to five, with clear implications for the value of this market. GlobalData estimates that the current SCLC US market value has crossed the US$1Bn mark, and that, with a number of ongoing label expansion trials for patients with limited-stage disease, this figure will only increase."
ENDS
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Notes to Editors:
Quotes provided by Sakis Paliouras, PhD, Oncology and Hematology Analyst at GlobalData
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