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Top Line: Gefitinib is currently a standard first-line therapy for EGFR-mutated non-small cell lung cancer (NSCLC), but it’s no cure.
The Study: The combo of gefitinib with cytotoxic chemo starts where most regimens contending the standard start: in the palliative setting. This phase 3 trial randomized patients receiving first-line palliative therapy for EGFR-mutated NSCLC to standard oral daily gefitinib monotherapy continued indefinitely +/- carbo/Alimta x 4 with maintenance Alimta. Of note, one-fifth of enrollees had brain mets. Rates of systemic radiographic responses were significantly improved with combo therapy from 63 → 75%, which translated to a doubling of the primary endpoint of progression-free survival from a median of 8 → 16 months. Importantly, this benefit held strong across all subset analyses. As expected, there was also a doubling in the rate of grade 3+ toxicity from 25 → 51%. This may give you pause considering this was all billed as palliative therapy, until seeing the statistically and clinically significant overall survival improvement with combo therapy producing a hazard ratio of 0.45. This makes this trial one of only two who have achieved such a feat for this disease in the last decade.
TBL: Following dacomitinib, combo gefitinib + carbo/Alimta is only the second systemic regimen in a long, long time to prove an overall survival advantage for advanced EGFR-mutated NSCLC ineligible for definitive surgery or radiation. | Noronha, J Clin Oncol 2019