BMS, Pfizer cancer drugs take starring roles at ASCO

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 Bristol-Myers Squibb's ipilimumab took the center ring at ASCO over the weekend, earning star billing for its promising data on melanoma. In a small trial, patients taking the drug lived a median of 10 months, compared to 6.4 months in a control group. And almost a quarter of the patients taking the therapy were alive after two years, compared to just 14 percent of the control group.

"This is the first randomized placebo-controlled trial ever to show a survival benefit in Stage 4 melanoma," said lead investigator Dr. Steven J. O'Day of the Angeles Clinic and Research Institute .And BMS says that it has the data it needs to pursue regulatory approval.

BMS needs a win on ipilimumab. The developer acquired full control of the program when it bought out Medarex for $2.3 billion and researchers have had to come up with new data to convince the FDA that the drug warrants an approval. The therapy spurs the body's T cells to fight off cancer and has been linked to some severe side effects.

Pfizer, meanwhile, was earning kudos for its lung cancer drug crizotinib, which stopped disease progression in 87 percent of the patients it was tested on. Researchers also tracked a reduction in tumor size among more than half of the patients--an impressive track record for mid-stage results. The drug is designed to treat lung cancer among patients with a defect in the ALK gene, something that occurs in five percent of the lung cancer population. Analysts say that the drug could earn about $800 million a year if larger studies confirm the data released at ASCO over the weekend.  

Japanese researchers played a key role in highlighting the potential of crizotinib by flagging the role of ALK in the development of lung cancer. The drug is in Phase III now and slated for a regulatory filing next year. Analysts say they're watching this program particularly closely to see if Pfizer has the pipeline it needs to overcome the loss of patent protection on Lipitor.

Eribulin, a chemotherapy made from a sea sponge, extended the median survival times of women with metastatic breast cancer who had already been extensively treated by 2.5 months. That's a 23 percent advantage over a group of patients who received another chemo drug selected by the patient's physician. The drug is being developed by Eisai.

"Eribulin targets the... mechanisms by which the cells divide, which is different from previous agents," said study author Dr. Christopher Twelves, who heads the Clinical Cancer Research Groups at the Leeds Institute of Molecular Medicine.

AstraZeneca, meanwhile, reported today that vandetanib, which blocks a protein implicated in tumor growth as well as the blood vessels that feed tumors, reduced the risk of thyroid cancer progression by 54 percent. Researchers say they don't know yet whether the benefit on disease progression will translate into an improvement in overall survival.

Further back in the pipeline is GDC-0449, a drug that targets the sonic hedgehog pathway, which is implicated in a variety of cancers. Researchers have been reviewing the drug's safety in a small trial for medulloblastoma, a brain cancer in children, and found that 12 children were able to take the drug without major side effects and one went a full year with no disease progression.

There's also a lot of attention being paid to Amgen's Prolia, which the FDA recently approved for osteoporosis. If Amgen can prove that Prolia can help prevent bone problems for cancer patients analysts will give Prolia a solid shot at megablockbuster sales of $3 billion a year.

ALSO: Researchers say that about half of the women enrolled in a small mid-stage trial of NKTR-102 benefited from the therapy. "These results demonstrate that NKTR-102 holds great therapeutic potential for women battling ovarian cancer," said Dr. Ignace Vergote, head of obstetrics and gynecology and gynecologic oncology at the Catholic University of Leuven, Belgium. Report

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