Targeted Pulse: Social Determinants Link to Cervical Cancer, FDA News, and More

Frontline Nivolumab/Ipilimumab Shows Survival Gains in HCC

The combination of nivolumab (Opdivo) and ipilimumab (Yervoy) has shown meaningful improvement to overall survival (OS) for patients with previously untreated advanced hepatocellular cancer. The combination was compared with the investigator’s choice of sorafenib (Nexavar) or lenvatinib (Lenvima) in CheckMate -9DW trial (NCT04039607) in the first line setting.

“The overall survival benefit demonstrated by the combination … demonstrates its potential to improve outcomes compared to well-established [tyrosine kinase inhibitor] treatment options,” Dana Walker MD, MCSE, said. Walker is vice president, global program lead of gastrointestinal and genitourinary cancers at Bristol Myers Squibb.

Connecting the Dots Between Cervical Cancer Risk and Economic Status

A recent analysis presented at the 2024 SGO Annual Meeting on Women’s Cancer showed that regions with a higher percentage of low-income households were correlated with decreased screening rates and higher cervical cancer burden. Poverty level was also associated with recurrent/metastatic cervical cancer burden in the Southern regions. For the analysis, investigators developed the Cervical Cancer Geo-Analyzer tool, which was designed to allow for the visualization of cervical cancer and recurrent/metastatic cervical cancer burden across different regions of the US.

“Findings from this study [are] the first step to optimize health care resources allocations, advocate to minimize access barriers, and [tailor] education on modern treatment options to minimize disparities in outcomes for US patients,” presenting study author Tara Castellano, MD, and colleagues, wrote in a presentation of the data. Castellano is an assistant professor in the Department of Gynecologic Oncology at Louisiana State University in New Orleans.

Building Evidence for Frontline Triplet Therapy in Non–Small Cell Lung Cancer

Tremelimumab (Imjudo), durvalumab (Darzalex), and chemotherapy in the first-line setting sustain momentum with an update to the phase 3 POSEIDON trial (NCT03164616) in metastatic non–small cell lung cancer.

“After a median follow-up of more than 5 years, [POSEIDON] demonstrated a durable long-term overall survival [OS] benefit [when] adding a limited course of tremelimumab and durvalumab. The 5-year [OS] rate [for the triplet] was more than twice as high than chemotherapy,” Solange Peters, MD, PhD explained. Peters is professor and chair of the Medical Oncology and Thoracic Malignancies Programme, Department of Oncology at the University Hospital of Lausanne in Switzerland.

Candid Insights: Clinical Trial Recruitment For CLL/SLL

A discussion exploring the design of the phase 1/2 TRANSCEND CLL 004 study (NCT03331198) and the data supporting the approval of lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. Tanya Siddiqi, MD, also addresses future directions for upcoming clinical trials that are now enrolling patients. Siddiqi is a hematologist, associate professor, medical director in the Division of Lymphoma at City of Hope Orange County in Duarte, California.

“For patients who failed both Bruton’s tyrosine kinase [BTK] [inhibitors] and venetoclax, which we consider to be our best treatment options for [patients with] CLL, there are trials ongoing with other novel therapies like BTK … [Overall], send us patients for trials early. Patients themselves should look up and come for trial participation early. Do not miss the opportunity because these are all great drugs. There is no placebo…Everybody is [going to] get [a good] drug,” Siddiqi stated.

FDA’s ODAC Votes in Favor of Cilta-Cel in R/R Multiple Myeloma

The FDA’s Oncologic Drug Advisory Committee met recently and decided that the benefits associated with ciltacabtagene autoleucel (cilta-cel; Carvykti) outweigh the risks for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy. The meeting dialogue focused on the OS data from the CARTITUDE-4 study (NCT04181827).

“The review issues are that cilta-cel led to a significantly improved rate of progression-free survival, but with a decrement in OS in the first 10 months of the trial. The decrement in OS calls into question whether the risk/benefit assessment is favorable,” Rob Sokolic, MD, said. Sokolic is chief of malignant hematology branch, Office of Clinical Evaluation, Office of Therapeutic Products, Center for Biologics Evaluation and Research, FDA.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.