Abstract 61P
Background
In the CameL phase III study (NCT03134872), Camre + Carbo-Pem was superior to Carbo-Pem for PFS in patients (pts) with previously untreated, advanced non-squamous NSCLC without EGFR/ALK alterations. Here, we present the updated outcomes after a follow-up of approximately 5 yrs.
Methods
Pts were randomized (1:1) and received 4–6 cycles of Camre (200 mg) plus Carbo-Pem (n=205) or Carbo-Pem (n=207) Q3W, followed by maintenance Camre + Pem or Pem only. Crossover from Carbo-Pem group to Camre monotherapy was permitted after disease progression. Total Camre exposure was up to 2 yrs.
Results
As of May 28, 2023, with a median follow-up duration (i.e., time from randomization to data cutoff) of 65.2 mo (range, 59.7‒72.2), there were 139 (67.8%) deaths in the Camre + Carbo-Pem group and 157 (75.8%) in the Carbo-Pem group. Median OS was 27.1 mo (95% CI, 21.9‒31.5) with Camre + Carbo-Pem vs. 19.8 mo (95% CI, 15.9‒23.7) with Carbo-Pem (HR, 0.74 [95% CI, 0.58–0.93]; 1-sided p=0.0043). The 5-yr OS rate was also higher with Camre + Carbo-Pem compared with Carbo-Pem (31.2% [95% CI, 24.7%‒37.9%] vs. 19.3% [95% CI, 13.9%‒25.3%]). Totally, 95 (45.9%) pts crossed over from the Carbo-Pem group to receive Camre monotherapy. After adjustment for crossover, the OS benefit with Camre + Carbo-Pem was more pronounced (adjusted HR, 0.62 [95% CI, 0.49–0.79]; 1-sided p<0.0001). Among the 33 pts in the Camre + Carbo-Pem group who completed 2 yrs of Camre, ORR was 97.0%; median DoR was 59.6 mo (95% CI, 31.3–not reached); and 5-yr OS rate was 84.3% (95% CI, 66.4%–93.2%). No new safety signals were noted, and no obvious evidence of cumulative toxicity was found with long exposure to Camre.
Conclusions
Camre + Carbo-Pem as first-line therapy continued to exhibit a clinically meaningful improvement in OS over Carbo-Pem, with manageable toxicity. Pts who completed 2 yrs of Camre had durable response and remarkable OS benefit. The 5-yr updated analysis further supports Camre + Carbo-Pem as a standard-of-care for previously untreated, advanced non-squamous NSCLC without EGFR/ALK alterations.
Clinical trial identification
NCT03134872.
Legal entity responsible for the study
Jiangsu Hengrui Pharmaceuticals.
Funding
Jiangsu Hengrui Pharmaceuticals.
Disclosure
C. Zhou: Financial Interests, Personal, Other, lectures, presentations, speakers’ bureaus, manuscript writing, or educational events: Amoy Diagnostics, Boehringer Ingelheim, C-Stone, Hengrui, Innovent Biologics, Lilly China, LUYE Pharma, Merck Sharp & Dohme, Qilu, Roche, Sanofi, and TopAlliance Biosciences Inc; Financial Interests, Personal, Other, on data safety monitoring boards or advisory boards: Hengrui, Innovent Biologics, Qilu, and TopAlliance Biosciences Inc. Z. Wang, X. Ma: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals. All other authors have declared no conflicts of interest.