- Celgene's Abraxane failed a pivotal Phase 3 study when combined with another chemotherapy as an adjuvant treatment in pancreatic cancer, the biotech disclosed Tuesday.
- The late-stage trial compared Abraxane plus gemcitabine to gemcitabine alone, evenly splitting 866 patients between the two arms. The Abraxane combo, however, failed to improve disease-free survival among these patients, who had surgically resected pancreatic adenocarcinoma.
- Celgene, which is in the process of being acquired by Bristol-Myers Squibb, did not provide any data in the top-line release. The Abraxane arm did achieve "nominal statistical significance" in improving overall survival, a secondary endpoint, and its safety profile was consistent with prior research, Celgene said.
Pancreatic cancer has seen few treatment advances, even as the prognosis for other tumor types such as melanoma, breast and prostate cancers has improved considerably.
The chemotherapy combo of Abraxane (paclitaxel) and gemcitabine has already been OK'd by the Food and Drug Administration as a first-line treatment for metastatic pancreatic cancer in patients who are not candidates for surgery. A successful trial could have helped Celgene push for a label expansion for Abraxane's use following surgery. Outside of pancreatic cancer, the drug holds approvals in breast cancer and non-small cell lung cancer.
Celgene's fresh clinical setback follows other recent attempts in pancreatic cancer that have fallen short. A couple months ago, treatment with AbbVie and Johnson & Johnson's Imbruvica (ibrutinib) with chemotherapy failed to improve progression-free or overall survival in a Phase 3 study of metastatic pancreatic cancer.
However, AstraZeneca's PARP inhibitor, Lynparza (olaparib), did show success as a maintenance treatment in certain pancreatic cancer cases, according to a Phase 3 topline readout last month.
First approved in 2005, Abraxane is an older treatment but is still widely used — sales broke the $1 billion threshold for the first time in 2018, totaling $1.06 billion. Roughly two-thirds of those sales came from the U.S.
Last year, Celgene inked a few settlement deals over generic Abraxane, allowing the drug to go generic in about three years, with Teva's Actavis set to enter the market first on Mar. 31, 2022.
Nadim Ahmed, Celgene's president of global hematology and oncology, briefly mentioned this late-stage study on the biotech's last earnings call in January, saying then the company was looking forward to seeing the data.
The short Tuesday disclosure, tucked behind last week's news of an accelerated approval in breast cancer for a combination of Roche's Tecentriq and Abraxane, did not provide any numbers, saying data will be submitted to a future medical meeting.