FDA Grants Pembrolizumab Priority Review for TMB-High Tumors
April 07, 2020 04:24pm
By Lisa Astor
As the new coronavirus disease 2019 creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.
As the new coronavirus disease 2019 (COVID-19) creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.
“I think for all of us it’s the unknown, and we’re all trying to be very flexible and nimble in our approach,” Vicki Caraway RN, BSN, Vice President of Clinical Services for American Oncology Network, said in an interview withTargeted Oncology. “It’s about keeping our patients safe. Because they are immunocompromised, and a lot of the patients that we see are older and have comorbidities, the onus is on us to come up with policies and procedures to keep everyone safe.”
The coronavirus is a family of viruses which are common in people and animals and causes severe diseases such as SARS (severe acute respiratory syndrome), MERS (Middle East respiratory syndrome), and SARS-CoV-2the cause of COVID-19.1
Oncology providers are feeling the effects of the virus as multiple oncology meetings in March have been canceled due to the outbreak, the FDA has warned of potential drug supply shortages, and academic facilities throughout the world, including in the United States, have decided to place travel bans on the faculty members at their institutions.
The European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2020, scheduled for March 2 through 4 in Paris, was canceled due to the spread of the virus through Europe, including France; French health authorities say that there are 423 confirmed cases and 5 deaths due to COVID-19, as of March 5.2,3
“In view of the spread of coronavirus infections across Europe and now increasingly in France, ESMO has made the difficult but necessary decision not to proceed with the TAT Congress,” the press release on February 28 stated.The ESMO TAT Congress provides the oncology community with information on early phase clinical trials of new agents which evaluates specific targets to help guide decisions on patient selection.
The National Comprehensive Cancer Network (NCCN) postponed its 2020 Annual Conference that was originally planned for March 19 to 22 in Orlando, Florida. The conference gathers over 1500 oncology professionals for more than 30 educational sessions about state-of-the-art cancer care practices.4
“We have a moral and professional obligation to do what we can individually and collectively to minimize the spread of COVID-19,” Ronald S. Walters, MD, MBA, chair of the NCCN Board of Directors, and a breast medical oncologist at The University of Texas MD Anderson Cancer Center, said in the NCCN press release. “Under the current circumstances, due diligence means thoughtfully curtailing any non-essential travel or gatherings for people across the oncology care ecosystem.”
The European Organisation for Research and Treatment of Cancer (EORTC) Gastrointestinal group meeting on March 6 in Brussels, Belgium, and the Brain Tumour group meeting on March 18 and 19 in St. Gallen, Switzerland, have both been canceled. Other organizations with meetings coming up, such as the American Society of Community Oncology in May and June and Community Oncology Alliance in April, are closely monitoring news coming from the Centers for Disease Control and Prevention (CDC) for updates that will affect whether they need to be canceled.
Additionally, the Society of Gynecologic Oncology announced that the 2020 Annual Meeting on Women’s Cancer, scheduled for March 28 to 31 in Toronto, Canada, has been canceled in light of the outbreak with meeting organizers exploring virtual options. The American Association for Cancer Research Annual Meeting, scheduled for April 24 to 29 in San Diego, California, has been postponed. A rescheduled meeting will be planned for later this year.
“Whenever there is a meeting with updates and dissemination of knowledge, usually a person from practice goes there to get firsthand information, learn about it, and bring back to their individual practices,” Harsha Vyas, MD, president and CEO of the Cancer Center of Middle Georgia, explained in an interview. “When important meetings get canceled, it’s a major disruption in the dissemination of vital knowledge.”
These meetings would bring together physicians from all over the world, and in doing so, attending physicians could possibly bring the virus to new places it wouldn’t have reached otherwise. If that happened, it would also mean they might bring the disease to the patients in their community.
“Fortunately, [with] of these various internet platforms for meetings and communications, key thought leaders can still communicate, just not in a face-to-face setting,” Martin Palmeri, MD, MBA, an oncologist at the Messino Cancer Center in North Carolina, said in an interview. “I know that teleconferencing has become more prominent, particularly with the recent travel concerns.”
Palmeri is also optimistic despite the potential drug shortages discussed on the FDA statement about the medical supply chain in relation to COVID-19. According to a statement from the Commissioner of Food and Drugs at the FDA, Stephen M. Hahn, MD, on February 27, there is a potential for shortages of critical medical products in the United States or disruptions to drug supplies.5Palmeri feels that the FDA’s increased scrutiny of the drug pipelines and supply chains means it will be able to mediate any potential shortages before it affects patient care.
“About 7 or 8 years ago, there were critical shortages of several life-saving chemotherapy drugs and because of the problem, the FDA had implemented multiple processes where if it looked like a critical drug shortage was evolving, it had ways of increasing manufacturing in other facilities around the worldor at least to notify those companies that increase production is needed,” Palmeri explained. “Hopefully the lessons that we learned years ago with those drug shortages will help to identify any potential drug shortages in the current environment so there won't be any delays in providing critical treatments.”
Many cancer drugs have alternatives so even though medication may usually come from China, there are enough manufacturers or brands of that medication with similar efficacy from another country. “We're blessed that there has been a lot of research and development over the last 10 years and we have multiple alternatives to treat the same cancer,” Palmeri said.
For the same reasons conferences are being canceled or postponed to avoid travel, some of the large academic centers started taking precautions. New York University has cancelled all non-essential international University-related travel, including planned group trips and individual travel.6The University of California campuses, among others, have banned all non-essential travel to Italy, South Korea, and China.7
Vyas is worried that travel bans through the world will have an effect on clinical trials for oncology. “The oncology field is a global entity; it does not only depend on the United States,” he pointed out. “We may not see the kind of things people saw in China and it may not peak at that high a number in terms of COVID-19, but since development happens in different places and information is shared, if this trend continues, it will affect several clinical trials sites abroad which may affect clinical trial enrollment numbers and so on.”
“If the trend continues, since it's such a dynamic global field now, it is expected to slow down some of the momentum [in oncology],” Vyas said. “I don’t believe it's a permanent thing, but 2020 may not be a great year.”
“We want to keep the [patients] safe so we’re going to do everything in our power to do that and if that means having to change the way that we provide care, that’s what we’ll do,” Caraway said.
Editor Note: This article was updated on March 9, 2020, following a press announcement from the Society of Gynecologic Oncology.
This article was updated on March 11, 2020, following a press announcement from the American Association for Cancer Research.