ASCO 2015 Highlights

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.

Two weeks after the initial approval of tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, on November 10, 2022, the FDA approved this new immunotherapy, in combination with the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and platinum-based chemotherapy, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and no EGFR or ALK genomic alterations.

On November 10, 2022, the FDA approved brentuximab vedotin (Adcetris; Seagen) in combination with a chemotherapy regimen of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) for treatment-naïve pediatric patients aged ≥2 years with high-risk classical Hodgkin lymphoma. This is the first indication for brentuximab vedotin for pediatric patients. Brentuximab vedotin has an orphan drug designation for Hodgkin lymphoma.

Results from a new study found that radiation oncologists tend to discuss sexual side effects in women undergoing treatment for cervical cancer far less frequently than they discuss sexual side effects in men undergoing treatment for prostate cancer. These findings were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2022 by the study’s lead investigator Jamie Takayesu, MD, Radiation Oncology Resident, University of Michigan Rogel Cancer Center, Ann Arbor.