ASH Clinical News October 2016 | Page 14

Latest & Greatest ABIM and ACCME Partner to Produce CME Finder Tool Cancer Moonshot Panel Releases List of Top 10 Ways to Fight Cancer The Cancer Moonshot Initiative’s Blue Ribbon Panel, a 28-member panel of advisers that includes top cancer researchers and patient advocates, presented a report to the National Cancer Advisory Board that included 10 transformative research recommendations to meet the initiative’s goal of improving prevention, diagnosis, and treatment of cancer over the next five years. The report was accepted and sent to a Cancer Moonshot task force headed by Vice President Biden and composed of almost two dozen officials from federal agencies and departments. The recommendations include: 1. Establishing a network for direct patient involvement that encourages patients to engage and contribute to their comprehensive tumor profile data to expand knowledge about what therapies work, in whom, and in which types of cancer. 2. Creating a clinical trials network devoted exclusively to discovering and evaluating immunotherapy approaches. 3. Developing ways to overcome cancer’s resistance to therapy by identifying therapeutic targets through studies that determine the mechanisms that lead cancer cells to become resistant to previously effective treatments. The American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) partnered to produce the CME Finder – a web-based tool (cmefinder.org) that allows physicians to search for continuing medical education (CME) opportunities, providing information such as activity provider and type, end date, participation restrictions, and associated fees on CME activities registered for maintenance of certification (MOC) credit. The tool also sends completion information directly to ABIM once a physician completes a listed activity, and physicians do not have to take any further steps to record these MOC activities. The tool also sends completion information directly to ABIM once a physician completes a listed activity, and physicians do not have to take any further steps to record these MOC activities. FDA Approv es Ofatumumab Combination for Relapsed Chronic Lymphocytic Leukemia The U.S. Food and Drug Administration (FDA) approved ofatumumab in combination with fludarabine and cyclophosphamide for patients with relapsed chronic lymphocytic leukemia (CLL). The approval was based on the results of the open-label, phase III COMPLEMENT-2 study that found ofatumumab plus fludarabine and cyclophosphamide resulted in a longer median progression-free survival (PFS; the study’s primary endpoint) than fludarabine and cyclophosphamide alone. A total of 365 patients were randomized to receive: • 300 mg of ofatumumab on day 1 of the first cycle followed by 1,000 mg on day 8, with subsequent cycles dosed at 1,000 mg on day 1 plus fludarabine and cyclophosphamide (triplet combination; n=183) • fludarabine and cyclophosphamide alone (control; n=182) The task force also is working on a report about what the government can do to support the Moonshot initiative. View the complete Blue Ribbon Panel report at cancer.gov/research/ key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel. “We are expanding our collaboration to encourage CME providers to continue to innovate and create educational activities that blend medical knowledge and practice assessment opportunities, which allows us to seamlessly recognize a physician’s journey through self-directed learning,” said Richard J. Baron, MD, president and CEO of ABIM, in a press release. ABIM and ACCME plan to release additional MOC opportunities in the spring of 2017. The overall response rate in the ofatumumab-treated group was 84 percent, compared with 68 percent in the fludarabine and cyclophosphamide group (p=0.0003). Complete response rates were 27 percent versus 7 percent, respectively. The PFS in the ofatumumab-treated group was 28.9 months, compared with 18.8 months for patients treated with fludarabine and cyclophosphamide (hazard ratio [HR] = 0.67; 95% CI 0.51-0.88; p=0.0032). The duration of response was also longer in the triplet combination group (29.6 months vs. 24.9 months for the doublet; HR=0.77; 95% CI 0.56-1.05; p=0.0878). Treatment-related adverse events (AEs) were similar in both study arms. Grade ≥3 AEs occurred in 74 percent of those treated with the triplet regimen compared with 69 percent in the control group. Fifty-three percent of patients who received triplet therapy experienced grade ≥3 neutropenia versus 39 percent of those in the control group. Infusionrelated reactions occurred in 4 percent of those treated with the ofatumumab combination compared with <1 percent in the control group. Sources: National Cancer Institute, September 7, 2016; The Washington Post, September 7, 2016. Source: American Board of Internal Medicine press release, August 29, 2016. Source: Genmab press release, August 31, 2016. 4. Building a national cancer data ecosystem for sharing and analyzing cancer data so that researchers, clinicians, and patients can contribute data. 5. Intensifying research on the major drivers of pediatric cancers to improve the understanding of fusion oncoproteins and use new preclinical models to develop inhibitors that target them. 6. Minimizing cancer treatments’ debilitating side effects by accelerating the development of guidelines for routine monitoring and management of patient-reported symptoms. 7. Expanding the use of proven cancer prevention and early detection strategies to reduce cancer risk and cancer health disparities through approaches in development, testing, and broad adoption of these strategies. 8. Mining past patient data to predict future patient outcomes to standard treatments. 9. Developing a three-dimensional cancer atlas of human tumor evolution to document the genetic lesions and cellular interactions of each tumor as it evolves from a precancerous lesion to advanced cancer. 10. Developing new cancer technologies to characterize tumors and test therapies. 12 ASH Clinical News October 2016