KEY TAKEAWAYS
- The CameL phase 3 trial aimed to investigate the long-term efficacy and survival outcomes of Camre + Carbo-Pem vs Carbo-Pem in advanced non-squamous NSCLC patients without EGFR/ALK alterations.
- Researchers noticed sustained improvement in OS with Camre + Carbo-Pem as 1L therapy, supporting its role as a standard of care in advanced non-squamous NSCLC patients.
In the CameL phase III study, camrelizumab(Camre) + carboplatin (Carbo)-pemetrexed (Pem) demonstrated superiority in progression-free survival (PFS) compared to Carbo-Pem among previously untreated patients with advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) lacking EGFR/ALK alterations.
C. Zhou and the team aimed to present updated outcomes following a 5-year follow-up.
Researchers performed an inclusive analysis in the CameL phase III study, where patients were randomized (1:1) to receive either 4–6 cycles of Camre (200 mg) plus Carbo-Pem (n=205) or Carbo-Pem alone (n=207) Q3W, followed by maintenance Camre + Pem or Pem only. Crossover from the Carbo-Pem group to Camre monotherapy was permitted upon disease progression. Total exposure to Camre was up to 2 years.
About the outcomes, as of May 28, 2023, with a median follow-up duration (i.e., time from randomization to data cutoff) of 65.2 months (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 overall survival (OS) was 27.1 months (95% CI, 21.9–31.5) with Camre + Carbo-Pem vs. 19.8 months (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-year OS rate was higher with Camre + Carbo-Pem (31.2% [95% CI, 24.7%–37.9%]) compared with Carbo-Pem (19.3% [95% CI, 13.9%–25.3%]). A total of 95 (45.9%) patients 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 patients in the Camre + Carbo-Pem group who completed 2 years of Camre, the objective response rate (ORR) was 97.0%; median duration of response (DoR) was 59.6 months (95% CI, 31.3–not reached); and 5-year 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.
The study concluded that Camre + Carbo-Pem as first-line (1L) therapy consistently demonstrated a clinically meaningful improvement in OS compared to Carbo-Pem, alongside manageable toxicity. Patients who completed 2 years of Camre exhibited durable response and substantial OS benefit. The 5-year updated analysis further solidifies the role of Camre + Carbo-Pem as a standard-of-care treatment for previously untreated, advanced non-squamous NSCLC without EGFR/ALK alterations.
The trial was sponsored by Jiangsu HengRui Medicine Co., Ltd.
Clinical Trial: https://clinicaltrials.gov/study/NCT03134872
C. Zhou, G. Chen, Y. Huang, et al. (2024). “First-line camrelizumab (Camre) plus carboplatin (Carbo) and pemetrexed (Pem) for advanced non-squamous NSCLC: 5-yr outcomes of CameL phase III study.” Presented at ELCC 2024 (Abstract 61P).
