The randomized, placebo-controlled, double-blind phase 3 CALLA trial assessed the combination of durvalumab and chemoradiotherapy vs placebo and chemoradiotherapy.
At the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting, Jyoti S. Mayadev, MD, a radiation oncologist and professor of radiation medicine and applied sciences at the University of California, San Diego School of Medicine, spoke with CancerNetwork® about the rationale of the phase 3 CALLA trial (NCT03830866) assessing durvalumab (Infinzi) in combination with chemoradiotherapy (CRT) compared with placebo and CRT in patients with high-risk locally advanced cervical cancer.
Mayadev also explained how the trial could potentially fulfil unmet needs in a population of patients with recurrence rates that are in need of improvement.
Transcript:
Locally advanced cervical cancer continues to represent an unmet medical need, especially in patients who have node-positive and periodic node–positive disease for which recurrence rates have been historically more than 50%. As a community of radiation oncologists who specialize in cervical cancer we really want to improve upon outcomes for these patients with cervical cancer. At the same time, we know that the majority of cervical cancer is caused by human papillomavirus; we know that it's immunogenic. We've done a series of phase 1 trials through the National Cancer Institute [NCI] that have shown us that combining immunotherapy with chemoradiation, whether it's concurrently or sequentially, is safe and tolerable and has shown really nice signals of efficacy. With AstraZeneca as our study sponsor, we were able to move immunotherapy and chemoradiation in the up-front definitive setting for patients with high-risk, stage III/IV node-positive locally advanced cervical cancer.
The goal of the CALLA trial was to improve outcomes for patients with this disease. It was a randomized, placebo-controlled double-blinded phase 3 trial looking at durvalumab concurrently and sequentially with chemoradiotherapy vs placebo/chemoradiation.
Mayadev JS, Rong, Y, Toita T, et al. Durvalumab in combination with chemoradiotherapy (CRT) in locally advanced cervical cancer (LACC): radiotherapy (RT) delivery and subgroup analyses from CALLA. Presented at 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting; October 23-26, 2022; San Antonio, TX; LBA 03. Accessed October 27, 2022.