Pfizer's Melanoma Treatment Setback Has Bigger Implications

Implications: While disappointing for patients and caregivers, Pfizer's loss of a late-stage treatment for melanoma casts an even darker shadow on the ability of pharmaceutical and biotech companies to successfully bring new treatments to market. Coupled with other recent Phase 3 failures, this latest outcome points to the need for even more investment in better biomarkers.

Analysis: Pfizer's recent announcement that tremelimumab, an antibody therapeutic intended to treat advanced melanoma, was not better than the current Standard of Care (SOC) was surprising and disappointing to many. In the past year or two, Pfizer (torcetrapib) and others have reported the failure of promising candidates that had reached Phase 3 clinical trials.

While not shocking that late-stage candidates fail, it is troubling that these programs, which have presumably shown Phase 2 efficacy and tolerability, can be so hard to successfully move through Phase 3 to approval. The increased use of biomarkers for both safety and efficacy has been touted as the next big breakthrough in boosting drug development success. Oncology has been an area where biomarkers are well defined and expected to be predictive of successful clinical outcomes. Yet we still see failures like tremelimumab in Phase 3.