Yeon Hee Park, MD, PhD, on Metastatic Breast Cancer: Updated Survival Results of the Young-PEARL Study
2024 ASCO Annual Meeting
Yeon Hee Park, MD, PhD, of South Korea’s Samsung Medical Center and Sungkyunkwan University, discusses phase II findings on palbociclib plus exemestane with a GnRH agonist vs capecitabine in premenopausal patients with hormone receptor–positive, HER2-negative metastatic breast cancer (LBA1002).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
YoungPEARL study is a prospective randomized phase 2 study to compare palbociclib plus exemestane plus GnRH agonist versus capecitabine for premenopausal HR-positive HER2-negative metastatic breast cancers. Actually, this clinical trial was published and presented in 2019. According to that trial research, palbociclib plus exemestane plus GnRH antagonist showed a superior PFS compared to the capecitabine. Their median PFS was 20.1 months versus capecitabine, 14.4 months. This kind of real big research contributed to expansion of palbociclib plus AI label to include premenopausal population.
So now, here we reported updated overall survival research. Data cutoff is February 29th, 2024 with median follow-up duration of 54 months. So we follow up the updated PFS research to show the consistent superior PFS showed in palbociclib arm. Median PFS was 19.5 months versus 14 months of PFS shown in capecitabine arm. Hazard ratio in people was strongly enough to consider it's a big impact in terms of PFS.
And now, we show the overall survival research. There is no big difference between the two arm. Palbociclib arm showed the 54.7 months of PFS, and then capecitabine arm showed a remarkable PFS of 57.8 months. They did not show any difference, but it's 54 months of longer follow-up duration. Palbociclib arm showed a pretty consistent, longer overall survival of 54.8 months. So it's a really... Extended overall survival was shown in palbociclib arm. But palbociclib superior PFS did not lead to the overall survival benefit compare capecitabine arm. But capecitabine arm showed... Multivariate analysis showed the post-treatment CDK4/6 inhibitor was identified as a independent favorable factor for overall survival with statistical significance. So maybe post CDK inhibitor treatment contributed to extended overall survival in palbociclib arm.
The ASCO Post Staff
Laurence Albiges, MD, PhD, of Gustave Roussy, Université Paris-Saclay, discusses phase III findings showing that high baseline serum KIM-1 levels were associated with poorer prognosis but improved clinical outcomes with atezolizumab vs placebo in patients with renal cell carcinoma at increased risk of recurrence after resection. Increased post-treatment KIM-1 levels were found to be associated with worse disease-free survival (Abstract 4506).
The ASCO Post Staff
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and Thomas Powles, MD, PhD, of Barts Cancer Institute and the University of London, discuss phase III findings from two studies: the first, investigating enfortumab vedotin-ejfv and pembrolizumab vs platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer; and the second, looking at nivolumab plus gemcitabine and cisplatin vs gemcitabine and cisplatin alone in patients with lymph node–only metastatic disease enrolled in the CheckMate 901 trial (Abstracts 4581 and 4565).
The ASCO Post Staff
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia and The University of Sydney, discusses final results with up to 10 years’ follow-up data of the COMBI-AD study of patients with stage III BRAF-mutated melanoma who received adjuvant dabrafenib plus trametinib (Abstract 9500).
The ASCO Post Staff
Eva M. Ciruelos, MD, PhD, of Spain’s Hospital 12 de Octubre and the Instituto de Investigación Sanitaria Hospital 12 de Octubre, discusses phase II data showing that the combination of palbociclib, trastuzumab, and endocrine therapy improved progression-free survival in patients with previously treated PAM50 luminal A or B, HER2-positive advanced breast cancer, as compared with treatment of physicians’ choice (Abstract 1008).
The ASCO Post Staff
Omid Hamid, MD, of The Angeles Clinic and Research Institute, a Cedars-Sinai affiliate, discusses updated data on IMC-F106C, a novel bispecific protein that, in a phase I safety and efficacy study, exhibited clinical activity in patients with unresectable or metastatic cutaneous melanoma who were pretreated with immune checkpoint inhibitors. A phase III trial of IMC-F106C with nivolumab in the first-line setting of metastatic disease has been initiated (NCT06112314; Abstract 9507).