Big pharma joins NIH’s Cancer Moonshot for a biomarker hunt

Eleven drug companies are joining forces with the National Institutes of Health’s Cancer Moonshot mission to deliver immunotherapy to more patients in less time. A partnership launched today will expedite the discovery of cancer immunotherapy biomarkers, molecular bar codes that help doctors know how to treat a tumor and gauge how well a patient responds to a drug.

The Cancer Moonshot Task Force was initiated by former President Barack Obama in February 2016 and initially led by former Vice President Joe Biden. At a press conference this morning, NIH announced a $160 million, five-year commitment to a new Cancer Moonshot-backed program called the Partnership for Accelerating Cancer Therapies (PACT). The 11 industry partners will each contribute an additional $1 million a year for five years.

“We all agreed that separately we could do a lot, but together we could do it faster,” said NIH director Francis Collins. PACT will test and validate biomarkers across many cancer immunotherapy trials so that assays can be standardized and data compared between different research groups.

“Dramatic success has been achieved with immunotherapy for certain cancers,” Collins said, mentioning melanoma, leukemia, and lymphoma. “But even for those cancers, success does not happen for everyone.” When immunotherapy works well, the results are astounding, eradicating tumors in patients for whom all other treatments have failed.

Immunotherapy’s buzz is high following the U.S. Food & Drug Administration’s approval in August of Kymriah, the Novartis gene therapy that reprograms patient T cells to fight refractory or relapsed cancer. But the field’s potential also “has yet to be realized” for solid tumors, such as breast, colon, pancreas, and prostate cancer, Collins said.

These tumors express mutant proteins that the immune system could, in theory, be coaxed into targeting, he added. PACT will seek answers to why immunotherapy doesn’t yet work for all patients or all cancers.

Thomas Hudson, vice president of oncology discovery and early development at AbbVie, said the partnership could help identify patients who will respond well to therapies based on the molecular signatures of their cancer, and avoid recruiting patients who won’t. In addition to AbbVie, the industry partners include Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceutical, Novartis, and Pfizer.

“No company will have all the [immuno-oncology] drugs, and for the best therapies we will need to combine,” Hudson said, emphasizing another reason why the companies are collaborating in the otherwise highly competitive immuno-oncology field. More than 1,000 combination immunotherapy are trials in the works, and some researchers have been critical of the seemingly shotgun approach to pairing treatments. Hudson says biomarker development will help identify “science-driven” combinations.

FDA has played a behind-the-scenes role in developing PACT during the past two years. Collins suggested the agency has an interest in evaluating PACT’s biomarker evidence “as it comes in,” possibly to speed up drug review processes. Defining which biomarkers to make a priority will be an ongoing effort, Collins said, but he didn’t provide further specifics.