The Lynx Group

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO

Chicago, IL—Fewer than 7% of adults with cancer and even fewer minority patients participate in clinical trials, which negatively affects the ability to determine the safety and efficacy of new and investigational therapies. At ASCO 2019, 2 experts discussed strategies to overcome the barriers to clinical trial participation and to help enroll more patients with cancer in them.
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The 2 chimeric antigen receptor (CAR) T-cell therapies available so far—axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah)—may be considered cost-effective treatments for adults with diffuse large B-cell lymphoma (DLBCL), depending on the long-term outcomes of these patients, according to a recent cost-effective analysis (Lin JK, et al. J Clin Oncol. 2019 Jun 3. Epub ahead of print).
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Until recently, patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT), the multiagent regimen with lenalidomide (Revlimid) and dexamethasone was the standard of care. Results of the prespecified interim analysis of the MAIA trial demonstrated the benefit of adding daratumumab (Darzalex) to this combination therapy (Facon T, et al. N Engl J Med. 2019;380:2104-2115).
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Chicago, IL—At ASCO 2019, the FDA announced an oncology-specific pilot program for physicians and patients who are seeking access to investigational therapies. The expanded access pilot program is a concierge service, said Richard Pazdur, MD, Director, FDA’s Oncology Center of Excellence, who spoke at a press conference where the new program—Project Facilitate—was announced.
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Approximately 40% of patients with hormone receptor (HR)-positive, HER2-negative breast cancer have mutations in the PIK3CA gene. Although endocrine­based therapy is the standard treatment, acquired resistance remains a challenge.
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Chicago, IL—BLU-667, a novel inhibitor of RET, elicited responses in more than 50% of patients with RET fusion–positive advanced non–small-cell lung cancer (NSCLC), according to data from an ongoing phase 1 clinical trial presented at ASCO 2019.
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Chicago, IL—Expanded data from an early phase 1/2 clinical trial showed that treatment with repotrectinib, an investigational tyrosine kinase inhibitor (TKI) with potent selectivity against tumors with ROS1 rearrangement, induced a response in 9 of 11 patients with TKI-naïve, advanced non–small-cell lung cancer (NSCLC) and ROS1 fusion.
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Chicago, IL—With 475 cell and gene therapy companies in North America representing a business enterprise with approximately $20 billion, new immunotherapies are moving rapidly from the laboratory to the clinic. As chimeric antigen receptor (CAR) T-cell therapy makes its way from the academic to community setting, however, appropriate resources and infrastructure are required to ensure the safe and effective management of patients.
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Chicago, IL—Reprogramming patients’ immune cells to treat their cancer has become the front line of cancer therapy, with chimeric antigen receptor (CAR) T-cell therapy now approved by the FDA for several blood cancers. But translating this success to solid tumors remains a challenge. At ASCO 2019, ­Gianpietro Dotti, MD, Cancer Cellular Immunotherapy Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, discussed efforts to extend the application of CAR T-cell therapy to solid tumors
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On June 10, 2019, the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines of therapy. The FDA granted polatuzumab breakthrough therapy and orphan drug designations.
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