Advertisement


Richard S. Finn, MD, on Hepatocellular Carcinoma: Recent Data on Lenvatinib Plus Pembrolizumab

ESMO Congress 2022

Advertisement

Richard S. Finn, MD, of the Geffen School of Medicine at the University of California, Los Angeles, discusses primary phase III results from the LEAP-002 study of pembrolizumab, an anti–PD-1 therapy, plus lenvatinib, the orally available multiple receptor tyrosine kinase inhibitor, vs lenvatinib monotherapy in patients with advanced hepatocellular carcinoma (Abstract LBA34).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
The LEAP-002 study was a large phase three double blind placebo controlled study in advanced liver cancer in the frontline setting, evaluating the combination of Lenvatinib and Pembrolizumab versus Lenvatinib alone. This study was based on earlier data, a single arm phase one B study in the frontline setting with both these drugs, which showed very interesting activity. A 36% objective response rate, as well as a survival of over 21 months, which in the first line setting of liver cancer was a signal to pursue this definitive study. Lenvatinib has already approved in the front line setting in the United States and Pembrolizumab has accelerated approval in the second line setting. So in this study, we demonstrated that the overall survival with the combination was over 21 months, which was expected. However, the control arm performed much better than we expected. That is to say Lenvatinib had a survival of about 19 months in this population. If we look at historical data with Lenvatinib, from the REFLECT study, the pivotal study that got it approved, overall survival was about 13 and a half months. So unfortunately, the study did not meet its primary endpoint of overall survival. There was a dual primary endpoint of PFS, and again, at the primary analysis for PFS, there was no significant difference between the two arms. We did see that with longer follow up that there was a tail to the curve for Len Pembro, looking at the two year benchmark about 16% of patients did not progress with a combination, whereas 9% on single agent Lenvatinib did not progress. When we look at objective responses, the objective response rate with the combination was 25% in line with what we saw in the phase one B and Lenvatinib had a response rate of about 17 and half percent, which was in line with what was expected with single agent Lenvatinib. When we look at safety, there were really no new safety signals. The safety profile looked like single agent Lenvatinib, no added toxicity with Pembrolizumab, but at the end of the day, the study did not meet its end point. We did establish that the combination does prolong a long survival in advanced liver cancer and specifically Lenvatinib as a single agent in advanced liver cancer provided a survival of 19 months, which is really a reminder that this drug plays an important role in our patients with advanced liver cancer, even in this modern age of new combinations that are being evaluated and being approved.

Related Videos

Lung Cancer
Immunotherapy

Gérard Zalcman, MD, PhD, on Non–Small Cell Lung Cancer: Phase III Trial Findings on Nivolumab and Ipilimumab

Gérard Zalcman, MD, PhD, of France’s Bichat-Claude Bernard Hospital, Assistance Publique–Hôpitaux de Paris, discusses phase III results from the IFCT-1701 trial, which explored the questions of whether to administer nivolumab plus ipilimumab for 6 months or whether to prolong the treatment in patients with advanced non–small cell lung cancer (Abstract 972O).

Lung Cancer

Charles Swanton, PhD, on Non–Small Cell Lung Cancer Induced by Air Pollution

Charles Swanton, PhD, of The Francis Crick Institute, discusses a newly discovered mechanism of action for air pollution–induced non–small cell lung cancer in which particles linked to climate change appear to promote cancerous changes. The finding might pave the way for new potential approaches to lung cancer prevention and treatment (Abstract LBA1).

Gynecologic Cancers

Ana Oaknin, MD, PhD, on Cervical Cancer: New Findings on Cemiplimab in Recurrent or Metastatic Disease

Ana Oaknin, MD, PhD, of Barcelona’s Vall d’Hebron University Hospital, discusses an analysis of long-term survival from the EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial. Cemiplimab-rwlc is the first immunotherapy to demonstrate an overall survival benefit as a second-line monotherapy for patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy but not immunotherapy. The benefit was sustained in this population (Abstract 519MO).

Breast Cancer
Genomics/Genetics

Antonio Marra, MD, on Metastatic Breast Cancer: Patterns of Genomic Instability and Their Effect on Treatment

Antonio Marra, MD, of Memorial Sloan Kettering Cancer Center, discusses a mutational signature analysis that reveals patterns of genomic instability linked to resistance to endocrine therapy with or without CDK4/6 inhibition in patients with estrogen receptor–positive/HER2-negative metastatic breast cancer (Abstract 210O).

Kidney Cancer
Immunotherapy

Robert J. Motzer, MD, on Renal Cell Carcinoma: New Results With Nivolumab and Ipilimumab

Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III results of the CheckMate 914 trial, which explored the efficacy of adjuvant nivolumab plus ipilimumab vs placebo in the treatment of patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (Abstract LBA4).

Advertisement

Advertisement




Advertisement