December 2022, Vol 13, No 6

At the 12th Annual Summit of the Association for Value-Based Cancer Care (AVBCC) in 2022, held October 19-21, 2022, in New York City, a panel of experts from Upstream Partners discussed the current state of value-based agreements (VBAs) in pharma and what lies ahead. The session was moderated by Burt Zweigenhaft, PhD, DLitt, Executive Director and Co-Founder of AVBCC.

A shortened course of radiation therapy is safe and effective for men with high-risk prostate cancer, according to the results of the phase 3 Prostate Cancer Study 5 (PCS5) trial. These findings were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2022 by the study’s lead investigator Tamim M. Niazi, MD, Associate Professor, Radiation Oncology, and Radiation Oncologist, Jewish General Hospital, McGill University, Montréal, Québec, Canada.

Updated results from the ECHELON-1 clinical trial showed that the combination of brentuximab vedotin (Adcetris; BV) plus doxorubicin, vinblastine, and dacarbazine (AVD) as first-line therapy improves overall survival (OS) in patients with stage III-IV classical Hodgkin lymphoma compared with standard therapy with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). “It is a great honor and privilege to present updated results that are quite remarkable in untreated, advanced stage lymphoma,” said David J. Straus, MD, Attending Physician, Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, speaking at the National Comprehensive Cancer Network 2022 Annual Congress: Hematologic Malignancies.

New results from the PATHFINDER clinical trial suggest that a multicancer early detection blood test can accurately identify the presence of cancer in apparently healthy people. The test, known as Galleri (developed by GRAIL), uses cell-free DNA and machine learning to detect a common cancer signal across more than 50 cancer types as well as to predict cancer signal origin. Once the test is validated and refined further, it may revolutionize the way in which cancer is diagnosed and treated.

On August 16, 2022, President Biden signed the Inflation Reduction Act into law, marking the first time the US Government will place direct price controls on many drugs covered by Medicare. The Medicare Part D benefit will also be restructured, and an annual patient out-of-pocket cap will be introduced.

The 12th Annual Summit of the Association of Value-Based Cancer Care (AVBCC) in 2022 was the site of an encouraging and positive trend that is taking on more prominence in US healthcare: recognition, discussion of, and intervention around social determinants of health (SDoH). Although the concept that SDoH has an identifiable and actionable influence on health is not new, there are clear signs that thinking is moving more broadly beyond something we are considering to something we can actually use to improve healthcare.

On December 1, 2022, the FDA approved olutasidenib (Rezlidhia; Forma Therapeutics) capsules, an oral IDH1 inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test.

On November 14, 2022, the FDA accelerated the approval of mirvetuximab soravtansine-gynx (Elahere; ImmunoGen), an intravenous folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1 to 3 previous systemic treatments, regardless of previous use of bevacizumab (Avastin). Patients should be identified for treatment with mirvetuximab soravtansine by an FDA-approved test.

On October 25, 2022, the FDA accelerated the approval of teclistamab-cqyv (Tecvayli; Janssen Biotech), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who received ≥4 previous lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. The FDA granted teclistamab breakthrough therapy and orphan drug designations.

On October 21, 2022, the FDA approved tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, in combination with durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for the treatment of adults with unresectable hepatocellular carcinoma (HCC). The FDA granted tremelimumab an orphan drug designation for this indication.