Boston Biomedical is halting a late-stage study of its investigational drug, alongside older chemo therapies, after it failed to help pancreatic cancer patients.
The phase 3 trial was combining traditional cancer chemo agents Abraxane and gemcitabine with Boston Biomedical’s experimental oncology drug napabucasin, an oral therapy that is bioactivated by NQO1, which generates reactive oxygen species to affect multiple oncogenic cellular pathways, including the STAT3 pathway, which is expected to result in cancer cell death.
But this triple cocktail failed to move the needle for Boston, owned by Japanese-based parent company Sumitomo Dainippon Pharma (buying back in 2012 for up to $2.6 billion), and the trial will now be stopped.
No details were given (they are coming later), but the biotech said in a statement that the cocktail, which was being pitted against Abraxane and gemcitabine as a double therapy, “will be discontinued due to futility” in patients with metastatic pancreatic ductal adenocarcinoma.
“This decision is based on a recommendation by the independent Data and Safety Monitoring Board (DSMB), following a pre-specified interim analysis of futility at 50 percent of the total planned events. No new safety concerns were raised by the DSMB,” the company said in statement.
“Pancreatic cancer is an area of high unmet need and our hope was to develop a new therapeutic option for patients,” said Patricia Andrews, CEO of the company. “We are disappointed with the results of this interim analysis and would like to express gratitude to the trial participants, their families, investigators and staff for their efforts and contributions to this study.”
Failing a phase 3 is always tough, but pancreatic cancers are one of the toughest targets out there, and this only adds to the growing litany of failures in pancreatic cancer trials.
This cancer has a dismal outlook: According to Cancer Research UK, the five-year survival rate for this disease is a painful 3%, with one-year survival at just under 20%. Treatment is typically surgery, chemo and/or radiotherapy.
There was some hope at ASCO this year, however, when AstraZeneca’s PARP Lynparza slashed the risk of disease worsening or death by 47% in patients with germline BRCA-mutated pancreatic cancer that hadn’t progressed after an initial round of chemo.
It's not the end of the road for Boston’s drug, however, as it remains in late-stage testing for colorectal cancer, as well as in “earlier phase trials in multiple solid malignancies.” Just last month, the company said an interim analysis of the colorectal cancer trial showed it could continue. This study is adding napabucasin to Folfiri, itself a combo of chemo agents, with or without Roche’s Avastin.
But this isn’t the first time the drug has flopped: Back in 2014, when napabucasin was known as BBI-608, and in a repeat of its pancreatic failure, the drug’s late-stage test in colorectal cancer was also stopped after an independent monitoring board’s advice. This was when the drug was used as a monotherapy and came as it failed to clear an efficacy hurdle in the first interim analysis involving 97 patients. Hence, the company is now focused on combo approaches.