Feb. 21, 2017:

For more than 25 years, Lawrence Feldman, MD, has been researching and treating patients with lung and head and neck cancers. In all those years, there have been few times that rival the optimism he feels when he considers the recent discoveries and advances in cancer immunotherapy.

“Over the last couple of years, immuno-oncology has been very successful in both lung and head and neck cancer. It’s been a very exciting area,” Dr. Feldman, a researcher at the University of Illinois at Chicago, said.

The approval of the PD-1 checkpoint inhibitor pembrolizumab (Keytruda®) by the U.S. Food and Drug Administration, first in advanced melanoma, and more recently in advanced non-small cell lung cancer and head and neck cancer, has accelerated progress in the fight against cancer. Pembrolizumab is just one of many immunotherapy agents now being tested.

Yet, for all its promise, immunotherapy is not without its limitations. Dr. Feldman notes that roughly 20-25 percent of non-small cell lung cancer patients respond to PD-1 inhibiting agents such as pembrolizumab.

“While it’s an amazing advance in the treatment of these patients, we’re not benefitting the majority of patients, so we are looking very hard to find additional compounds or ways to improve the benefit of these drugs for more patients,” Dr. Feldman said.

A new Big Ten Cancer Research Consortium study is exploring the combination of pembrolizumab with one such compound, Imprime PGG, for metastatic non-small lung cancer in patients whose tumors progressed during or after treatment with first-line platinum-based chemotherapy.

The study, known as BTCRC-LUN15-017, is currently open to accrual at the University of Illinois Cancer Center in Chicago, with additional Big Ten CRC member sites expected to open in the coming months. Dr. Feldman is the study’s sponsor-investigator.

How the Drugs Work

The immune system’s cytotoxic T cells, when appropriately activated, can recognize and kill cancer cells. Unfortunately, cancers can defeat the attack of these killer T cells by turning up a protein known as PD-L1, which plugs into the PD-1 receptor on T cells, shutting down the killing function of these T cells.

Pembrolizumab blocks the interaction of PD-L1 with PD-1, unleashing the tumor-killing function of these cytotoxic T cells.

Imprime PGG, a phase 2 drug being developed by Biothera Pharmaceuticals, acts as an immunological “ignition switch” to activate a host of anti-tumor immune system responses. Notably, Imprime PGG provides the critical activating signals to enable cytotoxic T cells to recognize and kill cancer cells. Accordingly, by enabling robust T cell killing of cancer cells, Imprime PGG may enhance the therapeutic activity of pembrolizumab.

The FDA has not approved Imprime PGG to treat any disease, and the use of pembrolizumab with Imprime PGG is investigational. This means the FDA has not approved this combination of drugs to treat patients with advanced non-small cell lung cancer.

About this Study

BTCRC-LUN15-017 will be conducted in two parts, called phases. Phase Ib will determine the maximum safe dose of Imprime PGG in combination with pembrolizumab. Phase II will estimate progression-free survival, or the length of time the study drugs control the cancer before it worsens.

Patients with metastatic non-small lung cancer whose cancer worsened during or after treatment with platinum-based chemotherapy, may be eligible to participate in this study.

More information about this clinical trial, including full eligibility criteria, is available at www.clinicaltrials.gov, using Identifier NCT03003468.

This trial is supported by Merck Sharp & Dohme Corp. and Biothera Pharmaceuticals, Inc.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit http://www.bigten.org/.