A month after an FDA advisory committee recommended another Phase III trial rather than quick approval for Aveo Oncology’s lead product tivozanib, the company said it will lay off 140 workers—about 62% of its staff—and reposition the experimental kidney cancer drug for colorectal and breast cancer.
“I’m sorry the results weren’t as we had hoped, sorry for the employees, sorry for the investors, and sorry for the patients. However in these circumstances, we owe it to all three to move the company forward. And we need to do it with the assets, both scientific and financial, that we have,” Aveo CEO Tuan Ha-Ngoc told analysts this morning on a conference call. “Unfortunately, downsizing is a necessary part of this process.”
Aveo CFO David Johnston added that virtually all segments of Aveo will lose jobs—from clinical and regulatory operations, to the business-development operations recently expanded as the company planned on FDA approval for tivozanib: “The commercial organization that we had, including medical affairs, is being eliminated.”
Aveo’s evp and COO Elan Ezickson, will resign effective July 31 “to pursue new opportunities,” and be succeeded by Michael Bailey, now the company’s chief commercial officer, the company said in a statement.
Ha-Ngoc said Aveo had given up on tivozanib for renal cell carcinoma (RCC) after concluding an FDA approval was unlikely. The agency typically abides by the recommendations of its advisory panels—including the Oncologic Drugs Advisory Committee, which on May 1 voted 13–1 to recommend that FDA reject tivozanib for RCC.
ODAC questioned why data from Aveo’s TIVO Phase III clinical trial was heavy with results from Eastern European patients while failing to show a better rate of overall survival than any of five currently approved drugs for RCC. Aveo has cited other data from TIVO, which studied 517 patients, showing that tivozanib slowed down progression of the disease—though the trial also showed that patients using one of the approved drugs, Nexavar, showed a better overall survival rate.
Following ODAC’s vote, Astellas Pharma pulled financial support for future trials of tivozanib in RCC, and backed off earlier plans to file an application for marketing authorization in Europe. Ha-Ngoc would not comment this morning on FDA regulatory actions related to Aveo’s NDA for tivozanib since it remains under review with the agency.
The CEO insisted that Astellas remained committed to partnering with Aveo on the BATON Phase II clinical trials of tivozanib in triple-negative breast cancer and metastatic colorectal cancer. BATON is recruiting patients for the former, in which 147 patients will receive paclitaxel and will be randomized to tivozanib or placebo. The company finished recruiting earlier this year for the latter, in which more than 250 patients will be treated with FOLFOX 6 and randomized to tivozanib or Avastin.
Aveo expects to announce results from the colorectal cancer trial next year, and from the breast cancer trial in late 2014 or early 2015. The company said it also expects to continue developing the Phase I ERBB3 (HER3) inhibitory antibody candidate AV-203 and seek external collaborations to develop the hepatocyte growth factor inhibitory antibody ficlatuzumab, both for multiple tumors.
Aveo projected the restructuring will save it $190 million over two years, including the $7.5 million to $8.5 million the company will shell out in personnel-related charges.
“This is an incredibly sad day for Aveo,” Ha-Ngoc said.