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Amivantamab in EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study
Open accessAbstract
PURPOSE: Non–small-cell lung cancer (NSCLC) with epidermal growth factor receptor ( EGFR) exon 20 insertion (Exon20ins) mutations exhibits inherent resistance to approved tyrosine kinase inhibitors. Amivantamab, an EGFR-MET bispecific antibody with immune cell–directing activity, binds to each receptor's extracellular domain, bypassing resistance at the tyrosine kinase inhibitor binding site. METHODS: CHRYSALIS is a phase I, open-label, dose-escalation, and dose-expansion study, which included a population with EGFR Exon20ins NSCLC. The primary end points were dose-limiting toxicity and overall response rate. We report findings from the postplatinum EGFR Exon20ins NSCLC population treated at the recommended phase II dose of 1,050 mg amivantamab (1,400 mg, ≥ 80 kg) given once weekly for the first 4 weeks and then once every 2 weeks starting at week 5. RESULTS: In the efficacy population (n = 81), the median age was 62 years (range, 42-84 years); 40 patients (49%) were Asian, and the median number of previous lines of therapy was two (range, 1-7). The overall response rate was 40% (95% CI, 29 to 51), including three complete responses, with a median duration of response of 11.1 months (95% CI, 6.9 to not reached). The median progression-free survival was 8.3 months (95% CI, 6.5 to 10.9). In the safety population (n = 114), the most common adverse events were rash in 98 patients (86%), infusion-related reactions in 75 (66%), and paronychia in 51 (45%). The most common grade 3-4 adverse events were hypokalemia in six patients (5%) and rash, pulmonary embolism, diarrhea, and neutropenia in four (4%) each. Treatment-related dose reductions and discontinuations were reported in 13% and 4% of patients, respectively. CONCLUSION: Amivantamab, via its novel mechanism of action, yielded robust and durable responses with tolerable safety in patients with EGFR Exon20ins mutations after progression on platinum-based chemotherapy.
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“Increased alanine aminotransferase 17 (15) 15 (13) 1 (1) 1 (1) 30 (12) 22 (9) 5 (2) 3 (1)”
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Metadata
- Authors
- Park, K., Haura, E. B., Leighl, N. B., Mitchell, P., Shu, C. A., Girard, N., Viteri, S., Han, J.-Y., Kim, S.-W., Lee, C. K., Sabari, J. K., Spira, A. I., Yang, T.-Y., Kim, D.-W., Lee, K. H., Sanborn, R. E., Trigo, J., Goto, K., Lee, J.-S., Yang, J. C.-H., Govindan, R., Bauml, J. M., Garrido, P., Krebs, M. G., Reckamp, K. L., Xie, J., Curtin, J. C., Haddish-Berhane, N., Roshak, A., Millington, D., Lorenzini, P., Thayu, M., Knoblauch, R. E., & Cho, B. C.
- Venue
- Journal of Clinical Oncology
- Published
- 2021-10-20
- Volume
- 39
- Issue
- 30
- Pages
- 3391-3402
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W3191219220
- Cited by
- 655
- References
- 31
- FWCI
- 64.54
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Park, K., Haura, E. B., Leighl, N. B., Mitchell, P., Shu, C. A., Girard, N., Viteri, S., Han, J.-Y., Kim, S.-W., Lee, C. K., Sabari, J. K., Spira, A. I., Yang, T.-Y., Kim, D.-W., Lee, K. H., Sanborn, R. E., Trigo, J., Goto, K., Lee, J.-S., . . . Cho, B. C. (2021). Amivantamab in EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.21.00662
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