Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Singh, Sonia; Jaigirdar, Adnan A.; Mulkey, Flora; Cheng, Joyce; Hamed, Salaheldin S.; Li, Yangbing; Liu, Jiang; Zhao, Hong; Goheer, Anwar; Helms, Whitney S.; Wang, Xing; Agarwal, Rajiv; Pragani, Rajan; Korsah, Kwadwo; Tang, Shenghui; Leighton, John; Rahman, Atiqur; Beaver, Julia A.; Pazdur, Richard; Theoret, Marc R.; Singh, Harpreet

doi:10.1158/1078-0432.22482252.v1

Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

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posted on 2023-03-31, 23:02 authored by Sonia Singh, Adnan A. Jaigirdar, Flora Mulkey, Joyce Cheng, Salaheldin S. Hamed, Yangbing Li, Jiang Liu, Hong Zhao, Anwar Goheer, Whitney S. Helms, Xing Wang, Rajiv Agarwal, Rajan Pragani, Kwadwo Korsah, Shenghui Tang, John Leighton, Atiqur Rahman, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh

Supplementary Table 1 shows adverse reactions occurring at a frequency of 10% or higher in patients with SCLC who received lurbinectedin in Study B-005. Supplementary Table 2 shows select laboratory abnormalities as worsening from baseline and occurring at a rate of 20% or higher in patients with SCLC who received lurbinectedin in Study B-005.

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ARTICLE ABSTRACT

On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was granted on the basis of the clinically meaningful effects on overall response rate (ORR) and duration of response (DOR), and the safety profile observed in a multicenter, open-label, multicohort clinical trial (PM1183-B-005-14, NCT02454972), referred to as Study B-005, in patients with advanced solid tumors. The trial included a cohort of 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. The confirmed ORR determined by investigator assessment using RECIST 1.1 in the approved SCLC patient population was 35% [95% confidence interval (CI): 26–45], with a median DOR of 5.3 (95% CI: 4.1–6.4) months. The drug label includes warnings and precautions for myelosuppression, hepatotoxicity, and embryo-fetal toxicity. This is the first drug approved by the FDA in over 20 years in the second line for patients with metastatic SCLC. Importantly, this approval includes an indication for patients who have platinum-resistant disease, representing an area of particular unmet need.

Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

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ARTICLE ABSTRACT

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