1193MO - Amivantamab plus lazertinib in post-osimertinib, post-platinum chemotherapy EGFR-mutant non-small cell lung cancer (NSCLC): Preliminary results from CHRYSALIS-2
Publication Title
ESMO Congress 2021: Mini oral session - NSCLC, metastatic
Document Type
Article
Publication Date
9-19-2021
Keywords
oregon; portland; chiles
Abstract
Background
The combination of amivantamab (ami), an epidermal growth factor receptor (EGFR)-MET bispecific antibody, with the 3rd-generation tyrosine kinase inhibitor lazertinib (laz), yielded a 36% overall response rate (ORR) in the post-osimertinib (osi), chemotherapy-naïve setting (Cho Ann Oncol 2020;31:S813, Oral 1258). The activity of ami + laz after progression on both osi and platinum doublet chemotherapy is unknown.
Methods
CHRYSALIS-2 (NCT04077463) is an ongoing open-label study that includes a single-arm cohort (Cohort A) examining ami + laz in patients (pts) with EGFR Exon19del or L858R NSCLC whose disease progressed after standard of care osi and platinum chemotherapy (3rd / 4th line; “target” population) and in more heavily-pretreated (5th line +) pts. Pts received the established recommended combination dose of 1050 mg IV ami (1400 mg, ≥80 kg) + 240 mg oral laz. Investigator-assessed response per RECIST v1.1 is reported for pts with ≥2 post-baseline disease assessments.
Results
As of 19 Apr 2021, 116 pts were enrolled in Cohort A (median 63 y, 68% women, 60% Asian, median of 3 [range, 2–14] prior lines), with 59 in the target and 57 in the heavily-pretreated populations. Of 28 response-evaluable pts in the target population, 12 (43% [95% CI, 24–63]) reported partial response (PR) as best response; of the 12 responses, 9 were confirmed (3 pending), for an overall response rate (ORR) of 32% (95% CI, 16–52). Of 45 pts in the heavily-pretreated population, 7 reported best response of PR, of which 6 were confirmed (1 pending), for an ORR of 13% (95% CI, 5–27). At 3.7-mo median follow-up, 17 pts in the target population remain on treatment: 10 with PR (3 pending confirmation) and 7 with stable disease. The safety profile for Cohort A was consistent with previously reported experience with ami + laz at the recommended combination dose, and no new safety signals were identified.
Conclusions
Ami + laz is showing encouraging early activity in a population that progressed on both standard of care osi and platinum chemotherapy. Activity is consistent with the post-osi population, suggesting intervening chemotherapy does not impact ami + laz activity.
Clinical trial identification
NCT04077463.
Clinical Institute
Cancer
Specialty/Research Institute
Earle A. Chiles Research Institute
Specialty/Research Institute
Oncology
