KEY TAKEAWAYS
- The phase 1 CHRYSALIS study evaluated amivantamab (ami) for treating advanced non-small cell lung cancer with EGFR Ex20ins mutations.
- Patients who had experienced disease progression on platinum-based chemotherapy were enrolled in the study.
- The study demonstrated the effectiveness of amivantamab in treating advanced NSCLC with EGFR Ex20ins mutations across diverse patient groups and prior treatment backgrounds.
The CHRYSALIS study reported the long-term outcomes of utilizing amivantamab (ami) to treat advanced non-small cell lung cancer (NSCLC).
Patients with EGFR Ex20ins advanced NSCLC who had experienced disease progression on platinum-based chemotherapy were selected for recruitment in the CHRYSALIS study. Those who were administered the approved phase II dose of 1050 mg (1400 mg if their weight was ≥80 kg) by June 8, 2020, were eligible for inclusion. The investigator evaluated the response to the treatment.
The trial included 114 individuals, with a median follow-up duration of 19.2 mo and 48 (42%) pts alive. Investigators assessed the overall response rate (ORR) at 37% (95% CI, 28-46) with a median duration of response at 12.5 months (95% CI, 6.9-19.3), the median progression-free survival (PFS) was 6.9 months (95% CI, 5.6-8.8), and the median overall survival was 23 months (95% CI, 18.5-29.5). The activity was observed across all subgroups, including the elderly (with an ORR of 32% and 33% for age ≥65 and ≥75, respectively), heavily pretreated pts (with an ORR of 53% for >2 prior lines, 42% for prior immunotherapy, and 52% for prior EGFR TKI therapy), or those sensitive or resistant to prior platinum-based chemotherapy (with an ORR of 36% and 31%, respectively). No new safety concerns were found. Rash (89%) and infusion reactions (67%) were common side effects. 42% of pts (n=48) were administered ami for 12+ cycles (28-day). Additionally, 13% of pts (n=15) are still undergoing treatment, with 11 positive responses and four with stable diseases. Patients took ami for a median of 2.6 years. An analysis will be presented by comparing sustained clinical benefit vs. no benefit (≥12 cycles on ami), including plasma ctDNA data.
Ami showed efficacy in post-platinum pts suffering from EGFR Ex20ins NSCLC, regardless of age, prior treatments, platinum sensitivity, or refractory status. Moreover, a subgroup of pts experienced extended benefits, which will undergo further scrutiny and examination.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02609776
Lopez, P.G., Girard, N., Cho, B.C., Sabari, J., Spira, A., Sanborn, R.E.E., Goto, K., Yang, J.C., Curtin, J., Lyu, X., He, A., Penton, J., Edwards, J., Massin, G.L., Xia, K., Chioda, M., Thayu, M., Knoblauch, R.E., Mahadevia, P., Leighl, N. Journal of Thoracic Oncology (2023).
