The ASCO 2013 Annual Meeting has come to a close and the over 25,000 attendees have returned home armed with new ideas around the advances in cancer treatment. The conference highlighted immunotherapies, breakthrough drugs and difficult issues facing the oncology community. Immunotherapies were the hottest new topic in oncotherapy development, you expect to hear much more about those treatment options in the future.
Vigorous discussions took place regarding the FDA’s new breakthrough drug designation. FDA regulatory officials present at these debates publicly assured attendees that they would focus on working closely with investigators in efforts to accelerate certain programs. “This is an exciting time for the oncology community, and I am sure you agree with me that the last decade has witnessed significant improvement in cancer drug development,” said FDA Commissioner Margaret A. Hamburg, MD, as she opened Sunday’s Plenary Session.
The buzz around immunotherapeutic agents and the breakthrough drug designation took center stage, but controversy caused by the federal government’s budget sequester dampened some of the excitement. Attendees expressed concern over the impact of the budget cuts on cancer treatments and a recent ASCO survey found that 80% of oncology practices had been impacted by sequestration.
With so many compelling sessions, important industry discussions and meaningful social media dialogue, it was difficult to decide what to include in our ASCO 2013 wrap-up; here are our takeaways from the conference:
The face-off between Merck and Bristol-Meyers Squibb over a new PD-1 antibody approach to stimulating an immune response to cancer was a blockbuster success. Both companies presented solid data on their respective drugs: lambrolizumab from Merck and nivolumab from Bristol-Meyers. Merck is preparing two late-stage clinical trials for non-small cell lung cancer in hopes of quickly scoring approval from regulators. Bristol-Meyers is conducting three phase III trials in melanoma, with additional late-stage trials in lung and kidney cancer. You can expect this to be an active area in cancer research.
Galena presented their NeuVax poster titled, Biomarker Correlation to Clinical Response in Phase I/II Trials of the Adjuvant Breast Cancer Vaccine, NeuVax (nelipepimut-S or E75). The poster examined the relationship between in vitro immunologic response (IR) and clinical recurrence (CR) after 5 years of follow up in breast cancer patients. The study concluded that patients with strong in vitro IR experience lower rates of recurrence. The 60-month trial demonstrated that patients with NeuVax had a 5.6 % rate of recurrence, while the control group showed a 25.9% recurrence. This works out to a reduction in recurrence rates of 78.4%.
Presenters at the Clinical Science Symposium, held on Monday, June 4th, reported that two novel agents going through early-phase analysis show dramatic and accelerated progress in treating non-Hodgkin lymphoma (NHL). The novel therapies, developed by Infinity Pharmaceuticals, Inc., directly target the phosphoinositide 3-kinase (PI3K) that supports growth and survival of T-cell and B-cell cancers.
The agents, known as IPI-145 and idelalisib, are initially demonstrating impressive results as monotherapy for NHL and mantle cell lymphoma (MCL), respectively. Dr. Steven Horowitz, M.D., Assistant Attending Physician, Department of Medicine, Memorial Sloan-Kettering Cancer Center, and an investigator for this trial said, “I’m encouraged by the early data seen in this Phase I study of IPI-145. So far, IPI-145 appears to be well tolerated, with responses seen across a broad range of B-cell and T-cell lymphomas.” This ignites great hope as to what these agents may achieve when used in combination regimens.
The federal government’s budget sequester, which slices 2% off the top of Medicare spending, is creating problems around the availability of cancer services according to a survey of members of the American Society of Clinical Oncology (ASCO; Alexandria, Virginia). In a May 9th statement ASCO highlighted recent survey findings indicating that half of participating oncologists have diverted at least one patient to another clinic due to the drop in Medicare funding, while 14% of respondents said they had stopped taking Medicare patients altogether.
The sequester amplifies an existing issue that has a decade of history behind it. The Medicare Modernization Act (MMA) of 2003 – which Congress used to trim payments for expensive cancer treatments in an effort to stanch what some policymakers saw as an abused reimbursement system – started the dynamic now in play. The sequester adds more price pressure on expensive cancer treatments forcing cancer clinic administrators to adjust the services they offer and, in some instances, closed less profitable clinics.
The ASCO survey disclosed that roughly half the respondents indicated they would continue to cover only those Medicare patients who carry supplemental insurance, while one in four indicated they would no longer participate in clinical research. More than one in five stated they “have or will need to close satellite clinics or outreach clinics, assuming the sequester cuts remain in place,” according to the ASCO statement.
Exiting ASCO President Sandra Swain, MD, said she found it encouraging “to see that oncologists are currently doing whatever they can to ensure that their patients receive the critical treatment they need under these funding cuts,” but she argued “patient care is clearly being disrupted in some cases and practices are under great stress. These early findings may just be the tip of the iceberg,” Swain asserted.
ASCO stated its support for a bill introduced by Rep. Renee Ellmers (R-North Carolina), the Cancer Patient Protect Act of 2013 (H.R. 1416). The legislation, which had the support of 75 members of the House of Representatives as of May 29, would override the effects of the sequester on Medicare Part B drugs, including cancer and supportive care drugs.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.