Pharm Exec's 2012 Pipeline Report - Pharmaceutical Executive


Pharm Exec's 2012 Pipeline Report

Pharmaceutical Executive

Cancer: Treating Patients Instead of Disease

Highly targeted therapies have made a comeback in cancer, with the approvals of Pfizer's Xalkori (crizotinib) and Roche/Daiichi-Sankyo's Zelboraf (vemurafenib) this year—both of which employ companion diagnostics, which dramatically improve patient outcomes. "In an era where more and more cancer drugs are failing because they don't demonstrate efficacy in the overall population, these 'magic bullets'—drugs that target specific genetic profiles—are going to revolutionize the market, at least for their niche target populations," says Kiran Meekings,a consultant at Thomson Reuters Life Sciences Consulting "We need to stop thinking about cancer as one, or several, diseases and instead we need to think about it as a set of distinct independent populations, each of which need a targeted set of treatments."

In pancreatic cancer, Clovis Oncology, a startup biopharma in Boulder, Colo., has fingers crossed over its CO-101 compound, a first-line treatment for metastatic pancreatic cancer. Clovis raised $130 million in its November IPO, and Roche is developing a companion diagnostic for CO-101 through its Ventana Medical Systems. This biomarker-driven clinical strategy could help Clovis succeed where others fail, given that C0-101 is a lipid-conjugated derivative of Gemzar (gemcitabine), Lilly's long-time treatment for the disease. Gemzar's efficacy as a single agent is moderate at best, however, with a median overall survival of just under six months; the drug is often coupled with other chemotherapy agents. Clovis estimates that "two-thirds of pancreatic cancer patients have limited cellular uptake of [Gemzar], due to deficient expression of hENT1—the transporter protein thought to facilitate cellular entry for Gemzar." CO-101's companion diagnostic would identify patients with low levels of hENT1 expression, which have been shown to correlate with poor Gemzar outcomes.

The multifactorial abnormalities in cancer—which means multiple targets—continues to present a problem, but several cancer drugs coming down the pipeline could do more than add a few months of progression-free survival. In hematology, Phase II data on Celgene's pomalidomide, an oral treatment for Revlimid and Velcade refractory patients with multiple myeloma, will be hyped during the American Society of Hematology meeting early this month. Onyx's carfilzomib, also for multiple myeloma, is the "most exciting thing to happen in multiple myeloma in maybe a decade," according to Selvaraju. Carfilzomib was fast-tracked by FDA in January for patients with relapsed or refractory multiple myeloma, and Onyx launched an expanded access program with the Multiple Myeloma Research Foundation in August, making the drug available to eligible patients across 40 medical centers in the US.

Medivation/Astellas' MDV-3100, discovered at UCLA, is an oral therapy being tested for prostate cancer; the drug received fast-track designation in November, after the company's AFFIRM trial data showed an almost five-month increase in median overall survival. If approved, MDV-3100 would compete with J&J's Zytiga, which has made inroads against Dendreon's Provenge vaccine; Provenge was expected to hit blockbuster sales figures, but hasn't performed as well as expected. However, CMS issued a National Coverage Decision last July, requiring Medicare contractors to cover the use of Provenge for treatment of asymptomatic or minimally symptomatic hormone refractory prostate cancer, which could standardize coverage and lift sales by the end of this year.


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