Cancer drug developers angling for center stage at ASCO

Posted under Ariad Pharmaceuticals, ArQule, Array BioPharma, ASCO, axitinib, Blog, breast cancer, cabozantinib, Cancer, Cancer Drugs, Companies, Diagnostics, Eli Lilly, Exelixis, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pipeline, renal cell carcinoma, Roche, Startups, Universities, Videos by john

Later this week the cancer drug research crowd will examine a tsunami of abstracts filed ahead of the ASCO meeting in early June in the hopes of finding a few new gems in the mountain of data being readied for the confab. ASCO is the place where anyone who's doing anything in cancer tries to make a splash in the spotlight. And with close to a thousand cancer drugs in the pipeline, that's no easy task.

Pfizer ($PFE) and Eli Lilly ($LLY) were both out bright and early this morning touting their work in the cancer arena. Pfizer's best hope at drawing attention lies in updating the data on axitinib, its recently approved treatment for renal cell carcinoma. And Lilly clearly hopes to impress analysts with ramucirumab, which is in 6 late-stage cancer studies.

Digging deeper, Executive Editor Ryan McBride's recent take on the top 10 cancer drugs in late-stage studies includes some of the closest watched therapies likely to elbow their way to center stage. Aveo ($AVEO) will be working hard to distinguish tivozanib--its kidney cancer drug with so-so head-to-head data with Nexavar--as it takes a monumentally important run at an approval later this year. Anything new on Roche's ($RHHBY) T-DM1 for breast cancer, which has racked up positive late-stage data on breast cancer on its way to an odds-on approval at the FDA, will be studied closely. Onyx ($ONXX) has the promising carfilzomib to tout, which is already at the FDA for review, while regorafenib (majority-owned by Bayer) is also in the media mix.

Today in Xconomy, the savvy biotech scribe Luke Timmerman assesses 8 drugs likely to make it into the center ring at ASCO. In addition to the drugs already mentioned, Timmerman includes abiraterone (Zytiga) from J&J ($JNJ) and Exelixis's ($EXEL) cabozantinib, a promising cancer drug that has earned Exelixis CEO Mike Morrissey both acclaim and exceptionally harsh criticism. The development program for cabo has been raked over the coals by a number of analysts. Medivation's enzalutamide (MDV3100), meanwhile, could wind up stealing the thunder for prostate cancer. And there's follow-up data from Ariad ($ARIA) on ponatinib.

Back in mid-March Adam Feuerstein at TheStreet got the first crack at an ASCO preview, listing prospects from Celldex, ArQule, Array BioPharma and Oncothyreon among the more frequently mentioned drug developers. But Celldex's ($CLDX) CDX-011 presentation was scrapped due to a clerical error. Now Celldex is planning a preemptive strike, with plans to hold a press conference of its own on May 23.

If you can't join them at ASCO, you can always try to beat them to the punch.

- here's the story from Xconomy
- read Adam Feuerstein's piece in TheStreet

Special Report: Top 10 Late-Stage Cancer Drugs - 2012

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UPDATED: Roche readies for approvals of previously snubbed breast cancer drug

Posted under Blog, breast cancer, Clinical Trials, Companies, Diagnostics, Eli Lilly, Funding, Herceptin, ImmunoGen, Medical Devices, Medical Supply, Pharmaceuticals, Phase III, Pipeline, Roche, Sanofi, Startups, T-DM1, Universities, Videos by rmcbride

Roche ($RHHBY) has turned in positive data from a key Phase III study of its blockbuster hopeful T-DM1 and later this year plans to seek green lights to sell the breast cancer drug in the U.S. and Europe, the company announced today.

The Swiss drug giant revealed top-line results from its 991-patient "EMILIA" study, saying that T-DM1, or trastuzumab emtansine, met one of the main goals of the study in providing a significant boost in survival without patients' cancer getting worse compared with patients who took the two cancer drugs lapatinib and Xeloda. The company didn't have available data on overall survival, which is the second primary endpoint of the study. Detailed results of the trial are expected at an upcoming scientific meeting.

Roche, which boasts the world's largest cancer drug business, sees T-DM1 as an encore to its drug Herceptin in treating HER-2 breast cancers, which account for 15% to 20% of all breast cancers. The experimental drug links Herceptin, an antibody drug, to the chemo agent DM1, providing what the company hopes will be a one-two punch that is more powerful in combating breast cancer than Herceptin or even Herceptin and separate doses of chemo. All patients in the EMILIA trial were previously treated with Herceptin and chemo.

The FDA turned down Roche's early bid for approval of T-DM1 in 2010, saying that the company's Phase II data weren't enough to win the agency's stamp. Roche is obviously upbeat about going back to regulators this year with Phase III results added to its data package for the program.

"We are excited about the EMILIA results because trastuzumab emtansine is our first antibody drug conjugate, and it may help people who still need more treatment options for this aggressive disease," Dr. Hal Barron, Roche's chief medical officer and head of product development, stated. "We will work to submit these data to regulatory authorities as quickly as possible."

ImmunoGen ($IMGN), which licenses its linker tech and the chemo agent for T-DM1 to Roche, could get its first revenue from sales of an antibody-drug conjugate if the drug is approved. To date, the Waltham, MA-based biotech relied on revenue from partnerships with Roche, Sanofi ($SNY), Eli Lilly ($LLY) and others. Biotech commentator Adam Feuerstein noted on Twitter this morning that ImmunoGen's royalty on T-DM1 sales is 5%.

- here's Roche's release
- check out the Reuters report
- get more from Dow Jones

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Corrected and updated: ImmunoGen doesn't license T-DM1 to Roche, as initially reported in this article. ImmunoGen licenses the linker technology and chemo agent DM1 used for T-DM1 to the drug company. We apologize for any confusion. The story was updated after the correction to add that ImmunoGen also licenses DM1 to Roche.

FDA rewards Roche with priority review for blockbuster cancer drug

Posted under Blog, breast cancer, Companies, Diagnostics, Funding, Genentech, Herceptin, Medical Devices, Medical Supply, pertuzumab, Pharmaceuticals, Roche, Startups, Universities, Videos by John Carroll

After racking up a solid set of late-stage data on the experimental breast cancer drug pertuzumab late last year, Roche ($RHHBY) and Genentech scored priority review status for the program, shaving months off of the regulatory process as it drives toward a likely blockbuster approval.

Pertuzumab fits the profile for the kind of new treatments regulators are enamored with. Added to Herceptin and chemotherapy the treatment delivered a median 6.1-month halt in tumor growth among women with HER2-positive breast cancer. The pertuzumab-Herceptin combo is being credited as a better HER2 blocker, and the added benefit comes without some of the potential side effects investigators have been fretting about. Scientists in the field have called it one of the biggest medical advances in several years.

Survival data isn't scheduled to arrive until next year, but the agency's decision to extend priority review status--shaving at least four months off the regulatory process--sends a clear signal that the FDA believes the potential benefits are well worth a regulatory shortcut. In recent months regulators have been handing out approvals on targeted drugs well ahead of deadline, indicating that they are ready to reward developers which can meet the standard on targeted drugs.

Analysts at Vontobel believe that an approval can add close to $2 billion a year in added revenue for Roche.

- read the press release
- here's the Reuters article

Special Report: Pertuzumab - 15 top blockbuster contenders

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Investigators tout promising breast cancer vax data from small study

Posted under Blog, breast cancer, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Investigators at the University of Pennsylvania say an experimental breast cancer vaccine designed to spur a patient's dendritic cells to attack cancer cells has proved promising in a small human study.

In the study, researchers extracted white cells from patients, armed them with pieces of HER2/neu protein, then injected them into 27 patients with HER2-positive ductal carcinoma in situ. Each patient was injected four times over a period of four weeks, with surgery afterward that aimed at removing any remaining cancerous tissue.

Study leader Dr. Brian Czerniecki said the immune systems of 5 of the patients evidently wiped out all signs of the disease, with HER2 expression eliminated in 11 patients and significantly reduced in two others. And Czerniecki says the same pattern is apparent in the second study.

"I think these data more than prove that vaccination works in situations where the target is right," says the scientist, according to a story in The Telegraph. "Previous vaccines targeted tissue antigens that were expressed on the cancer cells, but were not necessary for tumor survival. So a vaccine response would cause the tumor to just stop expressing the antigen and the tumor would be fine. Here we are going after HER2/neu, which is critical for survival of early breast cancers. If we knock it out with the immune response, we cripple the tumor cells."

- here's the story from The Telegraph
- get the UPI report

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