Addition of amivantamab improves PFS, response in lung cancer subset
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Key takeaways:
- The addition of amivantamab to chemotherapy significantly extended PFS.
- An interim OS analysis showed no statistically significant difference between the combination and chemotherapy alone.
MADRID — The addition of amivantamab to first-line chemotherapy improved outcomes for patients with advanced non-small cell lung cancer and EGFR exon 20 insertions, according to randomized phase 3 study results presented at ESMO Congress.
Patients assigned amivantamab (Rybrevant, Janssen) exhibited a 60% reduction in risk for disease progression or death, findings simultaneously published in The New England Journal of Medicine showed.
“Amivantamab plus chemotherapy represents the new standard of care for first-line [treatment of this population],” Nicolas Girard, MD, PhD, thoracic oncologist at Institut Curie in Paris, said during a presentation.
Amivantamab is approved for treatment of patients with advanced NSCLC who harbor EGFR exon 20 insertions and experienced disease progression during or after treatment with platinum-based chemotherapy.
The phase 1 CHRYSALIS trial showed antitumor activity of amivantamab combined with carboplatin and pemetrexed, according to study background. The combination also appeared safe.
Girard and colleagues conducted the international PAPILLON trial to evaluate the amivantamab-chemotherapy combination vs. chemotherapy alone as first-line treatment for advanced NSCLC with EGFR exon 20 insertions, a population for whom outcomes typically are poor.
The analysis included 308 patients who had not received prior systemic therapy. Researchers randomly assigned them 1:1 to IV amivantamab plus chemotherapy (n = 153) or chemotherapy alone (n = 155).
Treatment groups appeared balanced with regard to median age (61 years vs. 62 years), sex (56% women vs. 60% women), percentage of Asian patients (64% vs. 59%), and history of brain metastases (23% each).
Patients assigned chemotherapy alone could cross over to amivantamab monotherapy upon disease progression.
PFS assessed by blinded independent central review served as the primary outcome.
Secondary endpoints included objective response rate, PFS after first subsequent therapy (PFS2), OS and safety.
After median follow-up of 14.9 months, researchers reported significantly longer median PFS in the amivantamab-chemotherapy group (11.4 months vs. 6.7 months; HR = 0.4; 95% CI, 0.3-0.53). The PFS benefit with the combination remained consistent across subgroups.
A higher percentage of patients assigned the combination remained progression free at 18 months (31% vs. 3%) and achieved complete or partial response at data cutoff (73% vs. 47%; OR = 2.97; 95% CI, 1.84-4.79).
Median PFS2 was not estimable in the combination group and was 17.2 months for chemotherapy alone (HR = 0.49; 95% CI, 0.32-0.76).
An interim OS analysis — conducted at 33% maturity — showed a trend toward improved survival with the combination, but the difference did not reach statistical significance (HR = 0.67; 95% CI, 0.42-1.09). Two-thirds (66%) of patients assigned chemotherapy had crossed over to second-line amivantamab.
Grade 3 or higher adverse events occurred more frequently in the amivantamab group (75% vs. 54%). However, Girard noted the median treatment duration was longer in that group, as well (9.7 months vs. 6.7 months).
Seven patients (5%) in the amivantamab group and four (3%) in the chemotherapy group experienced adverse events that led to death.
Adverse events reported among at least 40% of patients assigned the amivantamab-chemotherapy combination included anemia, infusion-related reactions and hypoalbuminemia.
Seven percent of patients discontinued amivantamab due to treatment-related adverse events.
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Girard N, et al. Abstract LBA5. Presented at: European Society for Medical Oncology Congress; Oct. 20-24, 2023; Madrid.
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