After touting “positive results” in December and August for its Phase III cancer drug, Tesetaxel, Odonate Therapeutics is now discontinuing drug development and closing up shop.
No more Tesetaxel.
After touting “positive results” in December and August for its Phase III cancer drug, Odonate Therapeutics is now discontinuing drug development and closing up shop.
The company was built on the hopes of an easy-to-administer oral chemotherapy with fewer side effects for cancer patients. After licensing the drug, tesetaxel, from Daiichi Sankyo in 2013, Odonate went public, raising $173 million through an IPO in 2018. After a pre-New Drug Application meeting with the FDA showed approval to be unlikely, Odonate is pulling the plug.
Results from the Phase III CONTESSA trial showed tesetaxel in combination with existing chemo drug, capecitabine, did improve metastatic breast cancer patients’ progression-free survival by 2.9 months compared to capecitabine alone.
However, the less exciting news was data showing a 71% rate of neutropenia in patients treated with the drug combo, versus an 8.3% rate for patients treated with just capecitabine. Neutropenia is when a patient has too few neutrophils, a type of white blood cells. These are critical for fighting particular bacterial infections, so this type of deficiency leaves patients highly susceptible to infection.
With tesetaxel being its only drug candidate in the works, Odonate is shutting down company operations as well. The announcement said the company “will work with clinical sites to transition patients in ongoing tesetaxel clinical studies to appropriate alternative therapies.”
Pfizer also faced breast cancer drug disappointment with its drug, Ibrance just last fall. The study was particularly looking at women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant chemotherapy. The PENELOPE-B study failed to improve invasive disease-free survival.
Roche’s Genentech failed to increase progression-free survival for metastatic triple-negative breast cancer patients when combining its checkpoint inhibitor, Tecentriq, with chemotherapy.
At this time, metastatic breast cancer cannot be cured. Annually, the disease takes 40,000 lives. While 1 in 8 women will be diagnosed with breast cancer in the U.S., 1 in 3 of those will advance to metastatic.
