13.	Long-term efficacy, safety and predictors of response to amivantamab among patients with post-platinum EGFR exon 20 insert (Ex20ins)-mutated advanced non-small cell lung cancer (aNSCLC) — CHRYSALIS (NCT02609776)

P Garrido; Rachel E Sanborn; See full list of authors in comments

13. Long-term efficacy, safety and predictors of response to amivantamab among patients with post-platinum EGFR exon 20 insert (Ex20ins)-mutated advanced non-small cell lung cancer (aNSCLC) — CHRYSALIS (NCT02609776)

P Garrido, Rachel E Sanborn, See full list of authors in comments

Research output: Other contribution

Abstract

Background and Objectives: Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, is approved for patients with aNSCLC harboring EGFR Ex20ins mutations and progressed on prior platinum-based chemotherapy (PBC). This report presents long-term results.

Methods: Patients with EGFR Ex20ins aNSCLC whose disease progressed on PBC and who received the approved amivantamab dose of 1050mg (1400mg, ≥80 kg) by 08Jun2020 were included. Response was investigator-assessed per RECIST v1.1.

Results: By Sep2022 (N=114), median follow-up was 19.2 months, with 48 (42%) patients alive. Investigator-assessed overall response rate (ORR) 37% (95%CI, 28–46), median response duration 12.5 months (95%CI, 6.9–19.3), median progression-free survival 6.9 months (95%CI, 5.6–8.8), and median overall survival 23 months (95%CI, 18.5–29.5). Activity (ORR) was observed across subgroups, including elderly (32%/33% for age ≥65/≥75, respectively), heavily pretreated (53% >2 prior lines, 42% prior immunotherapy, 52% prior EGFR TKI therapy), or patients sensitive/resistant to prior PBC (36%/31%, respectively). No new safety signals detected. Rash (89%) and infusion-related reactions (67%) remained most frequent toxicities.

There are 48 (42%) patients on amivantamab for ≥12 (28-day) cycles. Treatment is ongoing in 15 (13%) (11 responders, 4 with stable disease as best response) who have received ami for a median 2.6 years. An analysis comparing patients without/with sustained clinical benefit (≥12 cycles on amivantamab) will be presented, including plasma ctDNA data.

Conclusions: Amivantamab demonstrated robust efficacy, consistently observed across PBC patients with EGFR Ex20ins NSCLC, including elderly, multiple prior lines, or platinum sensitive or refractory. A subgroup derived long-term benefit; the mechanisms to be explored further.

Original language	American English
State	Published - Apr 1 2023

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Name	Articles, Abstracts, and Reports

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@misc{cebb88fb87f942cb86f7d3b88cd2f410,

title = "13. Long-term efficacy, safety and predictors of response to amivantamab among patients with post-platinum EGFR exon 20 insert (Ex20ins)-mutated advanced non-small cell lung cancer (aNSCLC) — CHRYSALIS (NCT02609776)",

abstract = "Background and Objectives: Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, is approved for patients with aNSCLC harboring EGFR Ex20ins mutations and progressed on prior platinum-based chemotherapy (PBC). This report presents long-term results. Methods: Patients with EGFR Ex20ins aNSCLC whose disease progressed on PBC and who received the approved amivantamab dose of 1050mg (1400mg, ≥80 kg) by 08Jun2020 were included. Response was investigator-assessed per RECIST v1.1. Results: By Sep2022 (N=114), median follow-up was 19.2 months, with 48 (42%) patients alive. Investigator-assessed overall response rate (ORR) 37% (95%CI, 28–46), median response duration 12.5 months (95%CI, 6.9–19.3), median progression-free survival 6.9 months (95%CI, 5.6–8.8), and median overall survival 23 months (95%CI, 18.5–29.5). Activity (ORR) was observed across subgroups, including elderly (32%/33% for age ≥65/≥75, respectively), heavily pretreated (53% >2 prior lines, 42% prior immunotherapy, 52% prior EGFR TKI therapy), or patients sensitive/resistant to prior PBC (36%/31%, respectively). No new safety signals detected. Rash (89%) and infusion-related reactions (67%) remained most frequent toxicities. There are 48 (42%) patients on amivantamab for ≥12 (28-day) cycles. Treatment is ongoing in 15 (13%) (11 responders, 4 with stable disease as best response) who have received ami for a median 2.6 years. An analysis comparing patients without/with sustained clinical benefit (≥12 cycles on amivantamab) will be presented, including plasma ctDNA data. Conclusions: Amivantamab demonstrated robust efficacy, consistently observed across PBC patients with EGFR Ex20ins NSCLC, including elderly, multiple prior lines, or platinum sensitive or refractory. A subgroup derived long-term benefit; the mechanisms to be explored further.",

author = "P Garrido and Sanborn, {Rachel E} and comments, {See full list of authors in}",

year = "2023",

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language = "American English",

series = "Articles, Abstracts, and Reports",

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TY - GEN

T1 - 13. Long-term efficacy, safety and predictors of response to amivantamab among patients with post-platinum EGFR exon 20 insert (Ex20ins)-mutated advanced non-small cell lung cancer (aNSCLC) — CHRYSALIS (NCT02609776)

AU - Garrido, P

AU - Sanborn, Rachel E

AU - comments, See full list of authors in

PY - 2023/4/1

Y1 - 2023/4/1

N2 - Background and Objectives: Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, is approved for patients with aNSCLC harboring EGFR Ex20ins mutations and progressed on prior platinum-based chemotherapy (PBC). This report presents long-term results. Methods: Patients with EGFR Ex20ins aNSCLC whose disease progressed on PBC and who received the approved amivantamab dose of 1050mg (1400mg, ≥80 kg) by 08Jun2020 were included. Response was investigator-assessed per RECIST v1.1. Results: By Sep2022 (N=114), median follow-up was 19.2 months, with 48 (42%) patients alive. Investigator-assessed overall response rate (ORR) 37% (95%CI, 28–46), median response duration 12.5 months (95%CI, 6.9–19.3), median progression-free survival 6.9 months (95%CI, 5.6–8.8), and median overall survival 23 months (95%CI, 18.5–29.5). Activity (ORR) was observed across subgroups, including elderly (32%/33% for age ≥65/≥75, respectively), heavily pretreated (53% >2 prior lines, 42% prior immunotherapy, 52% prior EGFR TKI therapy), or patients sensitive/resistant to prior PBC (36%/31%, respectively). No new safety signals detected. Rash (89%) and infusion-related reactions (67%) remained most frequent toxicities. There are 48 (42%) patients on amivantamab for ≥12 (28-day) cycles. Treatment is ongoing in 15 (13%) (11 responders, 4 with stable disease as best response) who have received ami for a median 2.6 years. An analysis comparing patients without/with sustained clinical benefit (≥12 cycles on amivantamab) will be presented, including plasma ctDNA data. Conclusions: Amivantamab demonstrated robust efficacy, consistently observed across PBC patients with EGFR Ex20ins NSCLC, including elderly, multiple prior lines, or platinum sensitive or refractory. A subgroup derived long-term benefit; the mechanisms to be explored further.

AB - Background and Objectives: Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, is approved for patients with aNSCLC harboring EGFR Ex20ins mutations and progressed on prior platinum-based chemotherapy (PBC). This report presents long-term results. Methods: Patients with EGFR Ex20ins aNSCLC whose disease progressed on PBC and who received the approved amivantamab dose of 1050mg (1400mg, ≥80 kg) by 08Jun2020 were included. Response was investigator-assessed per RECIST v1.1. Results: By Sep2022 (N=114), median follow-up was 19.2 months, with 48 (42%) patients alive. Investigator-assessed overall response rate (ORR) 37% (95%CI, 28–46), median response duration 12.5 months (95%CI, 6.9–19.3), median progression-free survival 6.9 months (95%CI, 5.6–8.8), and median overall survival 23 months (95%CI, 18.5–29.5). Activity (ORR) was observed across subgroups, including elderly (32%/33% for age ≥65/≥75, respectively), heavily pretreated (53% >2 prior lines, 42% prior immunotherapy, 52% prior EGFR TKI therapy), or patients sensitive/resistant to prior PBC (36%/31%, respectively). No new safety signals detected. Rash (89%) and infusion-related reactions (67%) remained most frequent toxicities. There are 48 (42%) patients on amivantamab for ≥12 (28-day) cycles. Treatment is ongoing in 15 (13%) (11 responders, 4 with stable disease as best response) who have received ami for a median 2.6 years. An analysis comparing patients without/with sustained clinical benefit (≥12 cycles on amivantamab) will be presented, including plasma ctDNA data. Conclusions: Amivantamab demonstrated robust efficacy, consistently observed across PBC patients with EGFR Ex20ins NSCLC, including elderly, multiple prior lines, or platinum sensitive or refractory. A subgroup derived long-term benefit; the mechanisms to be explored further.

M3 - Other contribution

T3 - Articles, Abstracts, and Reports

ER -