Amgen (AMGN) Announces Cancer Survival Results when Faced with Vectibix in Combination with FOLFOX
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Amgen (NASDAQ: AMGN) today announced that the Phase 3 PRIME "203" trial evaluating Vectibix (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival. Earlier this year, it was announced that the trial met its primary endpoint by significantly prolonging progression-free survival (PFS) in the first-line treatment of patients with KRAS wild-type mCRC.
The prospective analysis of the 203 study showed that Vectibix, when added to a FOLFOX chemotherapy regimen in patients with KRAS wild-type mCRC, resulted in a median overall survival of 23.9 months compared to 19.7 months for patients treated with FOLFOX alone. The median overall survival difference of 4.2 months in the Vectibix arm did not reach statistical significance (HR=0.83, p=0.072).
Overall survival appeared to be reduced in patients with KRAS mutant tumors receiving Vectibix. Although not statistically significant, this result emphasizes the importance, as described in product labeling, of ensuring that patients receiving Vectibix do not bear tumors containing KRAS mutations.
Overall, the adverse event profile was as anticipated for an anti-EGFR antibody in combination with oxaliplatin-based chemotherapy, including known events such as rash, diarrhea and hypomagnesemia. Vectibix-related grade 3 infusion reactions were reported for two patients (less than 1 percent).
Originally designed to compare the treatment effect in the overall population, the study was amended to analyze outcomes with respect to the presence or absence of activating mutations in KRAS in the tumor itself. Tumor KRAS status was ascertained in more than 90 percent of the 1,183 patients enrolled in the trial.
Available results from the trial were presented earlier this year at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany showing that Vectibix significantly improved median progression-free survival by 1.6 months (9.6 versus 8.0 months for patients treated with FOLFOX alone, in patients with KRAS wild-type mCRC (primary endpoint). Further, the addition of Vectibix to chemotherapy also improved response rate in the KRAS wild-type patient population as measured by blinded central review (55 percent versus 48 percent in the FOLFOX only arm).
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