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.

 

Aveo Pharma flunks Phase II lung cancer study

Posted under AVEO Pharmaceuticals, Blog, Cancer Drugs, Clinical Trials, Companies, Diagnostics, ficlatuzumab, Funding, Medical Devices, Medical Supply, non-small cell lung cancer, Pharmaceuticals, Phase II, Startups, tivozanib, Universities, Videos by rmcbride

Aveo Pharmaceuticals ($AVEO) missed the main goal of a mid-stage study in Asia of its drug ficlatuzumab for treating non-small cell lung cancer. The Cambridge, MA-based drug developer said patients treated with a combination of the drug and gefitinib didn't show a statistically significant response when compared with patients who got gefitinib alone.

Aveo's share price slid a modest 30 cents, or 2.53%, to $11.77, as of 10:30 a.m. ET Wednesday.

For Aveo, the big attraction remains the company's lead drug tivozanib, for which executives aim to request FDA approval as a treatment for aggressive kidney cancer later this year. The promise of that program has likely cushioned the blow from the failed ficlatuzumab study.

The Phase II study failed to achieve its primary endpoint of improvement in overall response rate. The overall response rate for a group of patients who took Aveo's antibody drug in combination with gefitinib, which AstraZeneca ($AZN) markets as Iressa, was 43%, just a bit higher than the 40% overall response among patients took only Iressa to combat their lung cancers. Patients on the combo treatment lived for 5.6 months without their cancer getting worse compared with 4.7 months in the gefitinib-only group, according to Aveo.

The study appears have identified a subset of patients who benefited significantly from the combo treatment, and senior investigator Dr. Tony Mok of The Chinese University of Hong Kong says the finding warrants further study. 

- here's the release
- see Reuters' coverage

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Aveo on a hiring spree as it preps for the launch of tivozanib

Posted under Astellas Pharma, AVEO Pharmaceuticals, Blog, Companies, Diagnostics, Funding, Kyowa Hakko Kirin, Medical Devices, Medical Supply, Nexavar, Pharmaceuticals, Pipeline, Startups, TIVO-1, tivozanib, Universities, Videos by john

Early this year, when Aveo Pharmaceuticals published the data from its head-to-head matchup between its experimental kidney cancer drug tivozanib and industry standard Nexavar, analysts were so unimpressed by Aveo's ($AVEO) margin of victory on disease progression that the company's shares took a beating. But the Cambridge, MA-based biotech has been consistently upbeat about its market potential in the lead-up to its regulatory filing, and Aveo is going full steam ahead on its expansion plans.

The fast-growing developer tells The Boston Globe that it plans to hire 120 new staffers this year in preparation for the likely upcoming launch of tivozanib, which delivered a median PFS rate of 11.9 months compared with Nexavar's 9.1 month rate in a late-stage study. Tuan Ha-Ngoc, president and chief executive officer of Aveo, also pronounced himself "delighted with the favorable safety profile observed in TIVO-1."

Despite the mixed reception, tivozanib remains one of the most closely watched late-stage cancer drugs in the industry. Its success at the FDA would mark a key turning point for Aveo, as it transforms itself from a developer into a more mature company with a drug to sell.

Aveo in-licensed tivozanib from Japan's Kyowa Hakko Kirin and partnered on the program with Astellas Pharma. Now it plans to file for an approval in the third quarter, setting up the prospects of a likely launch next year. At that point Aveo can find out just how well tivozanib can do against the market competition.

- here's the story from The Boston Globe

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UPDATED: Aveo shares sink on weak PhIII face-off with Nexavar

Posted under Astellas Pharma, AVEO Pharmaceuticals, Blog, Companies, Diagnostics, Funding, kidney cancer, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, Startups, tivozanib, Universities, Videos by John Carroll

Aiming at a regulatory filing for the experimental kidney cancer drug tivozanib later this year, Aveo Pharmaceuticals ($AVEO) unveiled a slate of late-stage data this morning designed to help build its case for superiority compared to Onyx's ($ONXX) Nexavar. Investigators concluded that tivozanib held the progression of advanced kidney cancer at bay for a median of 11.9 months, compared to 9.1 months for Nexavar, in a Phase III study. But the data failed to impress analysts or investors, who forecast rough market seas ahead, triggering a stinging drop in the biotech's share price this morning. 

Aveo's decision to shoot for superior head-to-head data ahead of an FDA application was a gamble, but tivozanib--one of the most closely watched cancer drugs in late-stage development--faces some major league competition following any prospective approval by the FDA. The developer's decision to pull off a head-to-head study underscores the growing realization that an approval these days is no guarantee of success as payers apply a variety of restrictions on new and expensive cancer treatments. Aveo wants to make a clear case for the drug ahead of a launch.

Aveo--which is partnered with Astellas on the drug--noted that the data looked even better among treatment-naïve patients, with a median progression free survival of 12.7 months compared to 9.1 months for Nexavar. But the data failed to impress investors. The biotech's shares slid a stinging 13% in early trading as analysts speculated about tivozanib's ability to compete with Pfizer's Sutent, indicating that Aveo fell short of convincing investors of the drug's best-in-class market potential.

"We are very pleased by these results, especially the PFS benefit demonstrated in the treatment naive population, which represents the most significant market opportunity for tivozanib," said Tuan Ha-Ngoc, president and chief executive officer of Aveo. "In addition, we were delighted with the favorable safety profile observed in TIVO-1. We would like to acknowledge the investigators and patients who participated in TIVO-1 for their important contributions and commitment to the treatment of patients with RCC."

- here's the press release

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