UPDATED: ASCO abstracts reveal added appeal for key cancer drug prospects

Posted under Array BioPharma, ASCO, AVEO Pharmaceuticals, Blog, Cancer, Cancer Drugs, Companies, Diagnostics, Funding, kidney cancer, Medical Devices, Medical Supply, Nexavar, Pfizer, Pharmaceuticals, Pipeline, rilotumumab, selumetinib, Startups, tivozanib, Universities, Videos by john

The avalanche of ASCO abstracts last night triggered a flurry of news reports about the most notable new data on experimental therapies to be revealed ahead of next month's big meeting in Chicago. Here are a few of the highlights:

Aveo Pharmaceuticals

Aveo Pharmaceuticals ($AVEO) is concentrating on new safety data to make the case that tivozanib will be superior to Nexavar in treating kidney cancer. Investigators already announced that patients taking the treatment gained several months of progression-free survival over Nexavar. Now the biotech's abstract reveals that the experimental therapy triggered fewer cases of serious hand-foot syndrome. And the company took the initiative to tout the fact that 35% of Nexavar patients had to interrupt treatment, compared to 18% in the tivozanib crowd. 

"I think the important point is that this is a next-generation VEGF TKI with a cleaner mechanism of action that's focused more intensely on the VEGF receptor, and the VEGF pathway appears to be the most critical pathway in kidney cancer, so if you can more selectively focus on that you can produce equivalent or better efficacy with less toxicity. That's the real potential value of tivozanib," Dr. Michael Atkins, a TIVO-1 study investigator and deputy director of the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC, tells FierceBiotech Executive Editor Ryan McBride.

Pfizer

The data dump included a look at some positive new mid-stage results for Pfizer's ($PFE) dacomitinib, an experimental lung cancer therapy. Three out of four patients in the study demonstrated a response to the treatment, according to Reuters. The preliminary median  progression-free survival rate for patients with advanced cases was an impressive 17 months. Three of the 92 patients in the study had to stop therapy due to toxicity. The drug inhibits a variety of proteins that spur cell division and the pharma giant has a number of studies underway to determine its overall potential.

 

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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Amgen pushes agenda for biosimilars on the FDA

Posted under Amgen, Aranesp, biosimilars, Blog, Cancer, Companies, Diagnostics, Enbrel, Epogen, FDA, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Regulatory, Startups, Universities, Videos, Watson Pharmaceuticals by rmcbride

Amgen ($AMGN) has some concerns as the U.S. progresses toward a regulatory pathway for biosimilars development. As one of the largest biotech drugmakers, the company plans to advise the FDA today to adopt standards to guard the safety, supply chain and understanding of the copycat biologics.

The Thousand Oaks, CA-base drugmaker is one of 30 organizations on the docket today for the FDA's informal stakeholder meeting to discuss regulation of biosimilars. Dr. Joseph Miletich, Amgen's senior vice president of R&D, plans to speak on behalf of his company, which is a major player in the biosimilars game. Besides the company's tie-up with Watson to advance cancer biosimilars, Amgen faces competition from knockoff versions of its biologics.

In a release this morning, Amgen revealed that Miletich plans to push for the agency to adopt rules which would put tracking systems in place and distinguish biosimilars from the originals, make clear to doctors and others that biosimilars aren't substitutes for the real thing unless the FDA deems them interchangeable, and keep high quality standards for production of biosimilar products.

Amgen clearly has an interest in protecting the company's franchise of biotech drugs such as Enbrel, Epogen and Aranesp. The company's deal with Watson excludes development of biosimilar versions of Amgen drugs. Yet there are literally hundreds of companies chomping at the bit to develop copycat version of biologics, if not in the U.S., than in emerging markets. And many have already debuted biosimilar products. 

Biogen Idec ($BIIB), Novartis ($NVS) and other large drugmakers are also investing in biosimilars but have an interest in safeguarding their intellectual property for biologics. Biosimilars are much larger and complex molecules than small-molecule generics, and there are major challenges to developing a copycat version of a biologic with the same properties and risk/benefit profile as the original.

"The biosimilar approval pathway is a new initiative in the U.S. with many scientific and administrative challenges and nuances," Miletich said in a statement. "It will be essential for FDA to clearly communicate to all stakeholders what biosimilar products are and are not."

- here's Amgen's release

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Bayer bolsters blockbuster case for regorafenib with new PhIII data

Posted under Bayer, Blog, Cancer, Clinical Trials, colorectal cancer, Companies, Diagnostics, Funding, gastrointestinal tumors, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, Phase III, Pipeline, regorafenib, Startups, Universities, Videos by john

Bayer has racked up a fresh set of preliminary late-stage data that will bolster its plans to market regorafenib for a range of cancers. The treatment, which bears a striking resemblance to sorafenib (Nexavar), registered a successful response for gastrointestinal stromal tumors in Phase III, adding to the positive data already gathered on colorectal cancer.

Just a few months ago Bayer agreed to pay Onyx ($ONXX) $160 million and a hefty royalty slice on regorafenib to settle the biotech's claim that Bayer scientists had secretly created an analog closely matched to sorafenib, their blockbuster cancer medication. Now that that dispute has been replaced by a partnership, Bayer is eager to move ahead on a new drug program that promises to deliver more than a billion dollars a year in new revenue. Bayer has set its sights on applying for an approval on colorectal cancer with plans to expand its use for other cancers.

In this latest trial Dana-Farber's George Demetri studied regorafenib in advanced cancer patients who weren't responding to existing medications. Bayer says the treatment hit its primary endpoint on progression-free survival. The data will be detailed at an upcoming scientific meeting.

About 200 patients were enrolled in the study, with a 2-to-1 mix getting 160 mg of regorafenib daily, three weeks on and one week off. And patients in the control arm whose disease progressed were offered regorafenib.

"GIST is a difficult disease to treat. Patients treated with currently available therapies have a high likelihood that their disease will progress, and there are no remaining treatment options for those patients whose prior therapies have failed," said Ted W. Love, the EVP for R&D at Onyx. "These clinical data will show regorafenib's activity in patients with previously treated GIST."

- get the press release
- here's the story from Bloomberg

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