Advertisement


Jason J. Luke, MD, on Melanoma Adjuvant Therapy: Final Analysis of KEYNOTE-716

2023 ASCO Annual Meeting

Advertisement

Jason J. Luke, MD, of the University of Pittsburgh Medical Center Hillman Cancer Center, discusses adjuvant pembrolizumab, which, in previous results, improved distant metastasis– and recurrence-free survival in patients with resected stage IIB or IIC melanoma vs placebo. After a median follow-up of 39.4 months, adjuvant pembrolizumab continued to show a benefit over placebo, with no new safety signals (Abstract LBA9505).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
Adjuvant therapy for melanoma has been shifting rapidly and really to the betterment to the patients that were treated in our clinics. KEYNOTE-716 was the placebo controlled phase three clinical trial that demonstrated that pembrolizumab improves recurrence-free and distant metastasis free survival for patients with 2B and 2C melanoma. And of course, the context for this clinical trial was that we've been using adjuvant therapy for stage three melanoma for several years, and yet it wasn't available for patients with stage two. But that being said, the melanoma specific survival of patients with stage 2B and 2C melanoma has been known to actually be worse than that for patients with stage 3A and 3B melanoma, and yet we couldn't treat them. So we launched KEYNOTE-716 really to try to level set the field to give access to patients for a treatment that we know works for patients with similar risk. So to update the study now, we're presenting Landmark 36 month data with a median of 39 months of follow-up, showing that the recurrence-free survival, but more importantly, distant metastases free survival continues to be maintained and in fact increases in magnitude of benefit with further follow up on the clinical trial. And these are very, very important data for multiple reasons. One, is that they really emphasize this point that patients with stage 2B and 2C melanoma are at high risk of recurrence. But more than that, that adjuvant pembrolizumab is now the standard of care that should be offered to these patients. Now, of course, there is nuance to the decision about whether or not to choose adjuvant therapy in the postoperative setting. We have to take into account the risks and the benefits. It's clear now that the benefits include more than a 4% reduction in the likelihood of distant metastasis. There are side effects that are associated with immunotherapy, immune related adverse events, which no doubt can take place and be life altering in up to 5% of patients. So that's really where the crux is. With an individual patient, is it worth it to consider an adjuvant therapy that can significantly reduce your risk, albeit potentially also enhance side effect profile? So I think these data are very important to level set the field. Again, this is a very rapidly moving field, and these data show the landmarks and the benchmarks of what we should expect moving forward. There are multiple adjuvant clinical trials, phase three randomized studies that are now looking to further enhance the standard of care. And these include checkpoint combinations with molecules targeting lag three and tigit, and more recently, the individualized neo antigen therapies that have looked very, very promising. And so we know now that patients with stage two should be included in those clinical trials, and in fact, they are. And I think for the future moving forward, the perioperative setting for adjuvant therapy really will include all patients with stage 2B all the way through stage four resected melanoma.

Related Videos

Colorectal Cancer

Cathy Eng, MD, and Thejus Jayakrishnan, MD, on Colorectal Cancer: Metabolomic Differences in Young-Onset vs Average-Onset Disease

Cathy Eng, MD, of Vanderbilt-Ingram Cancer Center, and Thejus Jayakrishnan, MD, of the Cleveland Clinic Taussig Cancer Institute, discuss significant differences in the citrate cycle, a core pathway of cellular metabolism associated with colorectal cancer. Metabolomic differences impacted by environmental exposures (arginine biosynthesis and dietary red meat) were also noted, suggesting possible links with younger age of onset in this disease (Abstract 3510).

CNS Cancers

Lisa M. DeAngelis, MD, and Ingo K. Mellinghoff, MD, on Glioma: Phase III Results on Vorasidenib

Lisa M. DeAngelis, MD, and Ingo K. Mellinghoff, MD, both of Memorial Sloan Kettering Cancer Center, discuss findings from the INDIGO trial showing that the IDH1/2 inhibitor vorasidenib improves progression-free survival for patients with residual or recurrent grade 2 glioma with an IDH1/2 mutation. These data demonstrate the clinical benefit of vorasidenib in this patient population for whom chemotherapy and radiotherapy are being delayed.

Bladder Cancer
Immunotherapy

Shilpa Gupta, MD, on Urothelial Carcinoma: Long-Term Outcome of Enfortumab Vedotin Plus Pembrolizumab

Shilpa Gupta, MD, of Cleveland Clinic, discusses the results from the EV-103 study and the unmet need for effective first-line therapies in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. After nearly 4 years of follow-up, the trial findings showed that enfortumab vedotin-ejfv plus pembrolizumab continues to demonstrate promising survival trends with rapid and durable responses in this population (Abstract 4505).

Kidney Cancer

Thomas E. Hutson, DO, PharmD, on RCC: Overall Survival Analysis of Lenvatinib, Pembrolizumab, and Sunitinib

Thomas E. Hutson, DO, PharmD, of Texas Oncology, discusses the 4-year follow-up results from the CLEAR study for patients with advanced renal cell carcinoma (RCC). The data showed that lenvatinib plus pembrolizumab continues to demonstrate clinically meaningful benefit vs sunitinib in overall and progression-free survival, as well as in overall and complete response rates, in first-line treatment (Abstract 4502).

Lung Cancer
Immunotherapy

Jonathan W. Riess, MD, on EGFR-Mutated Non–Small Cell Lung Cancer: What’s Next?

Jonathan W. Riess, MD, of the University of California, Davis Comprehensive Cancer Center, explores the findings of three important clinical trials in lung cancer treatment: whether to incorporate immune checkpoint inhibitors into the treatment of EGFR-mutated lung cancer, the importance of central nervous system activity in EGFR-mutant lung cancer, and new therapies for disease with EGFR exon 20 insertion.

Advertisement

Advertisement




Advertisement