|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
At the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, investigators presented phase 3 data comparing the oral tyrosine kinase inhibitor gefitinib (250 mg, PO QD [GEF]) vs GEF + pemetrexed 500 mg/m2 IV and carboplatin AUC 5 IV every 3 weeks for 4 cycles, followed by maintenance pemetrexed 500 mg/m2 IV every 3 weeks (GEF + C), in patients with advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer.
A total of 350 patients (median age of 54 years, 48% female, 84% never-smokers, 18% brain metastases) were randomly selected in a 1:1 ratio to the treatment arms, with the primary objective of assessing progression-free survival (PFS).
Participants were chemotherapy-naive, had an EGFR-sensitive mutation (exon 19, exon 21, or exon 18), and an ECOG performance status (PS) of 0 to 2 (21% with PS 2). Treatment continued until disease progression or toxicity intolerability; restaging occurred every 2 to 3 months. Follow-up ranged from 7 to 30 months, with a median follow-up of 17 months.
Results showed that GEF + C significantly improved PFS compared with GEF alone —estimated median PFS was 16 months (95% CI, 13.5-18.5) vs 8 months (95% CI, 7.0-9.0), respectively. The hazard ratio for disease progression or death was 0.51 (95% CI, 0.39-0.66; P <.0001).
GEF + C significantly improved estimated median overall survival compared with GEF (not reached vs 17 months [95% CI, 13.5-20.5]; hazard ratio for death, 0.45; 95% CI, 0.31-0.65]; P <.0001).
Adverse events of grade 3 or higher were reported in 75% of patients on GEF + C compared with 49.4% who were administered GEF, P <.001.
“Adding pemetrexed-carboplatin chemotherapy to gefitinib significantly prolonged progression-free and overall survival but also increased toxicity. Pemetrexed-carboplatin-gefitinib represents a new standard first-line therapy for EGFR mutant NSCLC,” the authors concluded.
Read more of Cancer Therapy Advisor‘s coverage of ASCO’s annual meeting by visiting the conference page.
Noronha V, Joshi A, Patil VM, et al. Phase III randomized trial comparing gefitinib to gefitinib with pemetrexed-carboplatin chemotherapy in patients with advanced untreated EGFR mutant non-small cell lung cancer (gef vs gef+C). Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 9001.