Pharma Strategy Blog

The First-Line Erbitux in Lung Cancer (FLEX) trial data has finally been published in The Lancet prior to this month's ASCO meeting.  The data appears to show that patients given chemotherapy plus cetuximab survived longer than those in the chemotherapy-alone group (median 11·3 months vs 10·1 months).  This median overall survival difference of 1.2 months was significant, although there appeared to be no difference in progression-free survival (PFS).

However, the overall cost of taking cetuximab with chemotherapy during that time would amount to approximately $62,000 for an extra month of life.  The article did not provide any information on whether the quality of life was improved by the addition of the EGFR therapy, nor did it elucidate which patients would most likely see the largest benefit from cetuximab, eg KRAS mutation status.

The full data is expected to be presented at ASCO later this month, so a more detailed update will hopefully be available then.  It will be interesting to see if different subtypes (squamous, non-squamous, KRAS mutation status etc) elicit different survival curves and response rates to help select patients most likely to respond to EGFR therapy.

{UPDATE: Corrected reference added}

Robert Pirker, Jose R Pereira, Aleksandra Szczesna, Joachim von Pawel, Maciej Krzakowski, Rodryg Ramlau, Ihor Vynnychenko, Keunchil Park, Chih-Teng Yu, Valentyn Ganul, Jae-Kyung Roh, Emilio Bajetta, Kenneth O'Byrne, Filippo de Marinis, Wilfried Eberhardt, Thomas Goddemeier, Michael Emig, & Ulrich Gatzemeier (2009). Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial The Lancet, 373 (9674), 1525-1531