Noted This Week
Presented at the European Society of Medical Oncology Congress 2021, two studies found that adding abiraterone acetate and prednisolone (AAP) to standard treatment with androgen deprivation therapy and docetaxel for hormone-sensitive prostate cancer lengthens survival compared with standard therapy alone. In PEACE-1, men with high-burden metastatic disease who received the AAP combination lived about 2.5 years longer without disease progression—and 18 months longer overall—than those who received standard care. The STAMPEDE trial found that after 6 years, men at high risk of developing metastatic disease who received the AAP combination for 2 years had an improvement in metastasis-free survival from 69% to 82%, and an improvement in overall survival from 77% to 86%.
Incyte announced that the FDA approved ruxolitinib (Jakafi) for chronic graft-versus-host disease (GVHD) in patients age 12 and older after one or two other therapies fail. The approval was based on the 329-patient, phase III REACH3 study comparing ruxolitinib to best available therapy (BAT) to treat chronic GVDH following allogeneic stem cell transplantation (N Engl J Med 2021;385:228–38). After 24 weeks, the overall response rate (ORR) was 49.7% for ruxolitinib compared with 25.6% for BAT. The median duration of response was 4.2 months and 2.1 months, respectively.
The FDA approved cabozantinib (Cabometyx; Exelixis) for patients age 12 and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following VEGFR-targeted therapy and who are ineligible for or refractory to radioactive iodine. The decision was based on the COSMIC-311 trial, in which patients received either cabozantinib or placebo with best supportive care. Median progression-free survival was 11 months for those who received cabozantinib compared with 1.9 months for those who received placebo. The ORR was 18% and 0%, respectively.
In addition, the agency authorized the marketing of software to assist pathologists in detecting prostate cancer. Paige Prostate is the first artificial intelligence–based software designed to identify areas on biopsy images that could be cancerous and flag them for review. In a clinical study, 16 pathologists examined 527 prostate images—171 of which showed cancer—with and without Paige Prostate. On average, the software improved pathologists’ detection of cancer by 7.3% compared with pathologists’ analyses alone.
A Delaware Chancery Court judge ruled that Takeda breached an agreement with AbbVie for failing to fulfill orders for the prostate cancer agent leuprolide (Lupron), maintain common good manufacturing practices, and keep a backup supply of the drug to prevent shortages. Takeda, the global supplier of the hormone therapy, manufactures it at a plant in Japan, but the company and the FDA discovered poor equipment maintenance, shortfalls in quality, and other problems at the plant in 2019 that have led to a short supply worldwide. A second trial will determine compensation for AbbVie’s lost sales.
New York, NY’s Memorial Sloan Kettering Cancer Center announced the establishment of a center focused on patients ages 15 to 39, a group that often faces special treatment and psychosocial needs. The Lisa and Scott Stuart Center for Adolescent and Young Adult Cancers will address underrepresentation of these patients in clinical trials; offer family planning and fertility services; tailor treatment to tumor biology, which could differ from older and younger patients; and make use of apps and social media.