Top 10 late-stage cancer drugs in 2012

Posted under BBI608, Blog, Boston Biomedical, cabozantinib, Cancer Drugs, carfilzomib, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Medivation, Pharmaceuticals, Pipeline, Startups, T-DM1, tivozanib, Universities, Videos, Xalkori by rmcbride

Thousands of experimental meds are winding their way through various stages of clinical trials today, and the largest category among the contenders is cancer drugs. Of the hundreds of cancer programs under surveillance at FierceBiotech, we've culled the most promising programs we could find.

We welcome contrary views about our picks, but we saw four of the 10 drugs we selected last year--Seattle Genetics' ($SGEN) Adcetris (brentuximab vedotin), Pfizer's ($PFE) Xalkori (crizotinib), Plexxikon's Zelboraf (vemurafenib, formerly code-named PLX4032) and Roche's ($RHHBY) Erivedge (vismodegib)--gain FDA approvals since last year. The others remain in the hunt for regulatory nods, and we've included many of them in this year's roundup.

Like in last year's edition of this report, we've emphasized drugs that are at the very least headed into late-stage development. Most of the programs featured have provided compelling safety and efficacy data, yet we also highlighted a lesser-known drug called BBI608 because it's an excellent example of how the field of new drugs targeting cancer stem cells has matured. Dainippon Sumitomo saw enough promise in the program to scoop up its developer, Boston Biomedical,in a deal that could be worth more than $2.6 billion.

Please alert us to what you think are glaring omissions and, importantly, tell us why those missing programs should have been included here. For instance, To be clear, we've only included drugs here that are new biologics or chemical entities that haven't been approved yet. -- Ryan McBride (Email | Twitter)

• BBI608 – 10 Promising Late-Stage Cancer Drugs – 2012
• Cabozantinib – 10 Promising Late-Stage Cancer Drugs – 2012
• Carfilzomib – 10 Promising Late-Stage Cancer Drugs – 2012
• Enzalutamide (formerly MDV3100) – 10 Promising Late-Stage Cancer Drugs – 2012
• Ponatinib – 10 Promising Late-Stage Cancer Drugs – 2012
• Regorafenib – 10 Promising Late-Stage Cancer Drugs – 2012
• Talimogene laherparepvec (OncoVex) – 10 Promising Late-Stage Cancer Drugs – 2012
• T-DM1 (trastuzumab emtansine) – 10 Promising Late-Stage Cancer Drugs – 2012
• Tivozanib – 10 Promising Late-Stage Cancer Drugs – 2012
• Zaltrap (aflibercept concentrate) 10 Promising Late-Stage Cancer Drugs – 2012

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

Related Articles:
Roche wins landmark approval for targeted cancer drug vismodegib
Roche trial buoys antibody-based delivery of cancer drugs
Roche's T-DM1 generates a fresh blast of positive PhII data
ImmunoGen touts new drug-delivering antibodies

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.

Roche wins landmark approval for targeted cancer drug vismodegib

Posted under basal cell carcinoma, Blog, Companies, Curis, Diagnostics, Funding, Genentech, Medical Devices, Medical Supply, Pharmaceuticals, Roche, Startups, T-DM1, Universities, Videos by John Carroll

Roche ($RHHBY) and Genentech won a landmark approval for the cancer drug vismodegib today. After gaining significant efficacy data from a Phase II study on basal cell carcinoma, the drug giant not only went straight to the regulators for a decision, they won the approval well ahead of the agency's decision deadline. And top regulators signaled that they would look kindly on other developers who take the same approach to targeted therapeutics.

"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects."

The treatment, which inhibits signaling in the Hedgehog pathway, was tested in one cohort suffering from locally advanced basal cell carcinoma and a separate cohort of metastatic patients. In the mid-stage study, which involved 104 patients, vismodegib demonstrated an ability to shrink tumors or heal visible lesions in 43% of the patients with locally advanced BCC and 30% of patients with metastatic BCC. The median progression-free survival rate for both groups was 9.5 months.

Vismodegib, which will be marketed as Erivedge, was developed in collaboration with Curis ($CRIS).

The approval may well help spur other developers to consider taking the same approach. But it won't be easy. Roche tried to get an approval for the impressive T-DM1 on mid-stage data, but the regulators wouldn't even consider that application. A big plus this time is the lack of any other treatments for these patients.

- here's the press release from the FDA

Related Articles:
Roche rushes new cancer drug to regulators on Ph2 data
Roche preps vismodegib app with "profound" efficacy data