NCI Formulary a Big Support for Cancer Moonshot

Described as a public—private partnership between the National Cancer Institute (NCI) and pharmaceutical and biotechnology companies, the NCI Formulary is built with the expectation that it will provide researchers rapid access to anticancer drugs for use in clinical trials. This would be particularly valuable for researchers trying to use combination therapies using agents manufactured by different pharmaceutical companies, which in turn can have a big impact on patient outcomes and also help get drugs to patients much faster—one of the objectives of Vice President Joe Biden’s Cancer Moonshot Program.

The NCI has developed a process that will eliminate the often lengthy negotiations that occur between academic researchers and pharmaceutical manufacturers. Investigators at NCI-designated Cancer Centers can use the agents within this formulary to conduct clinical trials under investigator-held investigational new drugs, as well as for pre-clinical research. NCI’s mediation is expected to streamline and smoothen the process for these researchers.

Currently, 6 pharmaceutical companies have partnered with NCI and contributed 15 targeted anticancer agents to the formulary (Table). “The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients," James Doroshow, MD, deputy director for Clinical and Translational Research, NCI, said in a press release. "It represents a new drug development paradigm that will enhance the efficiency with which new treatments are discovered.”

Table. Drugs Currently Included in the NCI Formulary

Drug Name

Company

Targets

Alectinib (Alecensa)

Genentech

ALK

Atezolizumab (Tecentriq)

Genentech

PD-L1

Bevacizumab (Avastin)

Genentech

VEGF

Cobimetinib (Cotellic)

Genentech

MEK

Ensartinib

Xcovery Holding Company LLC

ALK, TrkA, TrkC, ROS, EphA2, c-MET

Ipilimumab (Yervoy)

Bristol-Myers Squibb

CTLA-4

Larotrectinib (LOXO-101)

Loxo Oncology

NTRK-1, NTRK-2, NTRK-3 fusion proteins; TrkA/B/C proteins

LY3039478

Eli Lilly and Company

Notch

Nivolumab (Opdivo)

Bristol-Myers Squibb

PD-1

Obinutuzumab (Gazyva)

Genentech

CD20

Pertuzumab (Perjeta)

Genentech

HER2/neu

Prexasertib

Eli Lilly and Company

CHK1

Trastuzumab (Herceptin)

Genentech

HER2/neu

Vemurafenib (Zelboraf)

Genentech

BRAF V600 mutant, CRAF, ARAF, wild-type BRAF, SRMS, ACK1, MAP4K5, FGR

Vismodegib (Erivedge)

Genentech

Smoothened

The formulary has drawn inspiration from NCI’s Cancer Therapy Evaluation Program and the NCI-MATCH trial. The study design of NCI-MATCH requires agents from multiple drug manufacturers, tested alone or in combination after matching a patient’s mutation pattern. Doroshaw expects the number of pharmaceutical partnerships and drugs to double by the end of 2017.

A report developed by the Blue Ribbon Panel of experts appointed by Vice President Biden had identified lack of collaboration and the slow dissemination of discoveries and clinical data as some of the barriers to improving cancer delivery in the United States. Partnerships spearheaded by institutions like the NCI could help overcome some of them.