Gateway Blog – When COVID-19 struck this past spring the world seemed to stop. Country by country, state by state, we went into global quarantine to contain the pandemic’s spread while frontline health care workers and first responders battled to save lives. The pandemic severely disrupted cancer research and patient care on a global scale, and many cancer clinical trials were suspended as cancer centers reallocated resources to COVID-19 priorities. Countless patients around the world lost access to promising investigational therapies. While access has improved since the early days of the pandemic, all indications point to an enduring trend for the foreseeable future.
The pandemic may have stopped cancer research, but cancer didn’t stop for the pandemic.
Gateway Rises to the Challenge
To address this unprecedented threat to cancer care and clinical research, Gateway quickly focused on one clear goal: to bring cancer clinical trials to the patients’ doorstep, not requiring patients to go to the trials.
Continuing its commitment to cancer patients everywhere, this spring Gateway launched a new funding program for “decentralized” early phase clinical oncology studies that leverage technologies like telemedicine, wearables and mobile applications, and remote monitoring to improve patient access to clinical trials.
Announcement of the first round of funding attracted great interest from many of the world’s top cancer researchers and cancer centers. Gateway’s scientific advisors reviewed five promising research proposals in diverse areas, from mobile-health delivery of a comprehensive lifestyle counseling program for women with breast cancer, to a telemedicine platform for cervical cancer screening in China.
In July, Gateway awarded its first decentralized grant to Sameek Roychowdhury, MD, PhD, of The Ohio State University James Comprehensive Cancer Center for his early phase clinical trial that will offer a promising new targeted therapy to patients with certain rare solid tumor cancers.
Delivering Therapies to the Doorsteps of Patients
Mutations in ALK, a protein involved in cell growth and proliferation, have been found in several human cancers, including lung, kidney, breast and colon cancer. Alterations in the closely related ROS1 gene have also been associated with lung cancer. These discoveries have led to the development of targeted therapies such as the ALK-inhibitor brigatinib, which this past spring was approved by the US Food & Drug Administration for the treatment of ALK-positive lung cancer.
While ALK-inhibitors have been widely tested and shown to be effective against lung cancer, there is little data for their use in other advanced solid cancers. Dr. Roychowdhury and his team at The James aim to assess the overall response rate to brigatinib in patients with locally advanced or metastatic solid tumors (other than lung) with ALK or ROS1 mutations.
These gene mutations are extremely rare: across all solid tumor types, an estimated one percent harbor ALK or ROS1 gene mutations. Finding and recruiting enough patients to conduct a clinical trial of an ALK inhibitor was challenging enough for the OSU team in ordinary times. Doing so during a global pandemic would be nearly insurmountable.
Dr. Roychowdhury expects that more than half of these patients will benefit from treatment with brigatinib, even after having failed prior treatment with surgery, radiation and chemotherapy. With this in mind, he designed a decentralized Phase I clinical study with The James team leading care from Ohio in close coordination with patients’ local oncologists, delivering the study drug from OSU’s Outpatient Investigational Drug Pharmacy directly to patients for each treatment cycle. Patients will be assessed and monitored via telehealth consults without ever having to travel to Ohio unless they choose to do so.
With Gateway funding, Dr. Roychowdhury will use this innovative approach to bring an investigational therapy and the expertise of the specialized cancer treatment team at The James to patients across the country, offering new hope to people with rare cancers.
Through the Pandemic and Beyond
COVID-19 disrupted the world’s cancer research enterprise, and there is every reason to believe that the trend will continue. But there is another inspiring trend worth noting – the innovation of cancer researchers in finding ways to advance their lifesaving work by rethinking the classic centralized clinical trial model and designing exciting new decentralized approaches.
In 2020 and beyond Gateway intends to focus the majority of its funding on the decentralized grants program, which will help restore access for cancer patients everywhere to the most promising new cancer therapies.
Sources1. Cancer November 20, 2017
2. J Psychiatr Pract. 2011 Jul; 17(4): 270–276
3. Cancer.net PTSD and Cancer January 2016
4. The ASCO Post November 29, 2017
Living Better with Cancer