Amivantamab

A phase I, open-label, dose-escalation, and dose-expansion study (CHRYSALIS [NCT02609776]) investigated amivantamab, an EGFR-MET bispecific antibody, in several different patient groups. A total of 114 patients with EGFR exon 20 insertions who had received previous platinum-based chemotherapy received the recommended phase II dose of amivantamab (1,050 mg [1,400 mg if >80 kg] IV) once weekly for the first 4 weeks and then once every 2 weeks starting at week 5. The primary end point for the dose-expansion group was overall response rate.[29][Level of evidence C3]

A phase I, open-label, dose-escalation, and dose-expansion study (CHRYSALIS [NCT02609776]) investigated amivantamab, an EGFR-MET bispecific antibody, in several different patient groups. A total of 114 patients with EGFR exon 20 insertions who had received previous platinum-based chemotherapy received the recommended phase II dose of amivantamab (1,050 mg [1,400 mg if >80 kg] IV) once weekly for the first 4 weeks and then once every 2 weeks starting at week 5. The primary end point for the dose-expansion group was overall response rate.[29][Level of evidence C3]

At the time of clinical data cutoff, 81 patients were evaluable with at least three disease assessments. The overall response rate was 40% (95% CI, 29%–51%), including three complete responses. The median DOR was 11.1 months (95% CI, 6.9–not reached [NR]). The clinical benefit rate (including patients with stable disease) was 74% (95% CI, 63%–83%).

A phase I, open-label, dose-escalation, and dose-expansion study (CHRYSALIS [NCT02609776]) investigated amivantamab, an EGFR-MET bispecific antibody, in several different patient groups. A total of 114 patients with EGFR exon 20 insertions who had received previous platinum-based chemotherapy received the recommended phase II dose of amivantamab (1,050 mg [1,400 mg if >80 kg] IV) once weekly for the first 4 weeks and then once every 2 weeks starting at week 5. The primary end point for the dose-expansion group was overall response rate.[29][Level of evidence C3]

The median PFS was 8.3 months (95% CI, 6.5–10.9); OS data are not mature.

A phase I, open-label, dose-escalation, and dose-expansion study (CHRYSALIS [NCT02609776]) investigated amivantamab, an EGFR-MET bispecific antibody, in several different patient groups. A total of 114 patients with EGFR exon 20 insertions who had received previous platinum-based chemotherapy received the recommended phase II dose of amivantamab (1,050 mg [1,400 mg if >80 kg] IV) once weekly for the first 4 weeks and then once every 2 weeks starting at week 5. The primary end point for the dose-expansion group was overall response rate.[29][Level of evidence C3]

The most common adverse events were rash (86%), infusion-related reactions (66%), and paronychia (45%). Patients experienced adverse events related to both EGFR inhibition (rash, paronychia, stomatitis, pruritus, diarrhea) and MET inhibition (hypoalbuminemia, peripheral edema). Grade 3 or greater adverse events occurred in 35% of patients, with rash (4%) and infusion reactions (3%) as the most common.

A phase I, open-label, dose-escalation, and dose-expansion study (CHRYSALIS [NCT02609776]) investigated amivantamab, an EGFR-MET bispecific antibody, in several different patient groups. A total of 114 patients with EGFR exon 20 insertions who had received previous platinum-based chemotherapy received the recommended phase II dose of amivantamab (1,050 mg [1,400 mg if >80 kg] IV) once weekly for the first 4 weeks and then once every 2 weeks starting at week 5. The primary end point for the dose-expansion group was overall response rate.[29][Level of evidence C3]

The infusion reactions occurred primarily with the first exposure to amivantamab. The administration of the first dose was split over 2 days to minimize this toxicity.