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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Support seen for U.S. plan to speed nods for ‘breakthrough’ drugs

Posted under Blog, Cancer Drugs, Companies, Diagnostics, FDA, Funding, HIV, Janet Woodcock, Kalydeco, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Regulatory, Startups, Universities, Videos, Xalkori, Zelboraf by rmcbride

Drug companies have clamored for the FDA to provide a more efficient pathway to gain product approvals, and this year the agency and U.S. lawmakers appear to be supportive of a plan that would help pharma groups race to the market with breakthrough drugs.

As Reuters reports today, the plan is expected to become law this year, formalizing a regulatory pathway that allows the FDA to let drugmakers conduct speedier trials with fewer patients prior to approval when their treatments provide major benefits for patients. The system would be akin to the agency's accelerated approach to ushering life-sustaining HIV treatments onto the market.

U.S. regulators have shown a willingness to take urgent action on reviews of breakthrough drugs. For instance, the agency stamped an approval of Vertex's ($VRTX) cystic fibrosis therapy Kalydeco after a quick three-month priority review rather than the standard 10-month review period. And the agency has acted quickly on applications for string of cancer meds such as Pfizer's ($PFE) lung cancer drug Xalkori and Roche's ($RHHBY) Zelboraf for skin cancer that showed impressive results in the clinic, Reuters reported.

Such approvals helped the industry see an uptick in market nods for new drugs, yet there are still significant barriers in place that keep development cycles even for powerful new meds long and expensive. Dr. Janet Woodcock, the FDA's top drug regulator, has been a vocal advocate for giving the agency greater latitude to approve breakthroughs.

"What happens when you have a breakthrough drug that shows an effect that's never been seen before?" Woodcock said in March, as quoted by Reuters.

- check out Reuters' article

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FDA withdraws hold on GTx’s prostate cancer drug

Posted under Blog, Cancer Drugs, Clinical Trials, Companies, Diagnostics, FDA, Funding, GTx, Medical Devices, Medical Supply, non-small cell lung cancer, Pharmaceuticals, Prostate Cancer, Regulatory, Startups, Universities, Videos by rmcbride

GTx ($GTXI) is back on track to begin a mid-stage study of its drug Capesaris. The FDA lifted a clinical hold on the experimental cancer drug after reviewing the company's response and plans for a Phase II study involving patients with castration-resistant prostate cancer.  

Memphis-based GTx now aims to launch the mid-stage trial in the third quarter, testing the drug in 75 men at three lower doses, the company said today. The study aims to measure safety and efficacy of the hormone therapy in men with aggressive prostate cancers.

U.S. regulators placed the program on hold in February after GTx revealed to the agency an increased risk of clotting. The safety risk was seen in patients treated with higher doses of the drug than the company plans to test in the revamped Phase II trial. The upbeat development pushed the company's stock price up nearly 20% to $3.72 this morning, helping the price regain some lost ground since the clinical hold made news.

GTx also said today in a corporate update that the company is enrolling patients for two late-stage studies of Ostarine for combating muscle wasting in patients with advanced non-small cell lung cancer. The update included results for the first quarter, which said that the company had $64 million in cash equivalents and other short-term investments as of March 31.

- here's the release on Capesaris
- see Reuters' update

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GTx shares tumble after clot threat forces hold on prostate cancer drug