Congress passed—and U.S. President Joe Biden signed—appropriations bills to fund the government through September 30, averting a partial government shutdown set to begin on March 23. In the end, allocations for research generally did not keep pace with inflation. For example, the NIH will face a net decrease of about $378 million over fiscal year (FY) 2023, with its final budget tallying about $47.1 billion; the NCI’s appropriation dropped by about $96 million, bringing its total budget to about $7.2 billion. Passage of the bills was a long time coming, happening about 6 months after the start of FY 2024. During this time, government business chugged along thanks to a series of continuing resolutions that maintained spending at FY 2023 levels.
Regeneron Pharmaceuticals announced that the FDA has declined to approve odronextamab, a CD3xCD20 antibody that directs T-cell targeting of B-cell malignancies, to treat relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B-cell lymphoma. The company said that the agency “did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling, or manufacturing.” Rather, the U.S. drug regulator expressed concerns about the progress of confirmatory trials, saying that “timelines to completion” need to be agreed upon. For its part, Regeneron said it is “committed to working closely with the FDA and investigators to bring odronextamab to patients […] as quickly as possible.”
AbbVie announced that its antibody–drug conjugate mirvetuximab soravtansine (Elahere) was granted full approval to treat adults with folate receptor alpha (FRα)—positive, platinum-resistant ovarian cancer who’ve already tried as many as three therapies. The decision was based on results from the phase III MIRASOL trial, which showed an overall survival benefit—and a reduction of 35% in the risk of disease progression—in patients who received mirvetuximab soravtansine compared with investigator’s choice of chemotherapy. The drug also caused fewer grade 3 or higher adverse reactions and a lower rate of discontinuation than chemotherapy.
Bristol Myers Squibb announced that adagrasib (Krazati) met its primary endpoint—progression-free survival—in the KRYSTAL-12 confirmatory trial, which is evaluating the KRASG12C inhibitor in patients with KRASG12C-mutated locally advanced or metastatic non–small cell lung cancer (NSCLC); it also met a secondary endpoint—overall response rate. Details, which will be presented at an upcoming medical meeting, show that adagrasib offers a significant and clinically meaningful benefit compared with chemotherapy in patients who’ve already received some treatment, the company reported. The drug was granted accelerated approval by the FDA for this indication in December 2022.
Novocure revealed that the phase III METIS trial met its primary endpoint—a significant improvement in time to intracranial progression of up to 10 brain metastases in patients with NSCLC following stereotactic radiosurgery. The study assessed whether treatment with Tumor Treating Fields (TTFields) therapy plus supportive care would help these patients fare better than supportive care alone. Indeed, those treated with TTFields and supportive care exhibited a median time to intracranial progression of metastases of 21.9 months compared with 11.3 months for those who received only supportive care. However, secondary endpoints, such as OS, did not meet statistical significance; others, such as quality of life, showed positive trends.
In the United States, PBS’s American Experience aired “The Cancer Detectives,” which the media outlet describes as “the untold story of the first-ever war on cancer and the coalition of people who fought tirelessly to save women from cervical cancer—which was once the number one cancer killer of women.” The episode focuses on George Papanicolaou, MD, PhD, the creator of the Pap smear; Helen Dickens, MD, who crusaded to bring the Pap test to black women in Philadelphia, PA; and Hashime Murayama, a science illustrator whose sketches of uterine cells aided in the diagnosis of cancer. The documentary can be streamed at https://www.pbs.org/wgbh/americanexperience/films/cancer-detectives/.
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