Advertisement


Axel Hauschild, MD, on Melanoma: Findings From the PIVOTAL Trial of Daromun vs Surgery

2024 ASCO Annual Meeting

Advertisement

Axel Hauschild, MD, of Germany’s University of Kiel and University Hospital Schleswig-Holstein, discusses phase III study results on neoadjuvant intralesional daromun vs immediate surgery for patients with fully resectable, locally advanced melanoma (Abstract LBA9501).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
I'd like to report about a study which was called PIVOTAL. It's a clinical trial on Daromun, a new agent which was not discovered so far in a Phase III trial. The trial design is very simple. It was a one-to-one randomization of 260 patients. In one arm is surgery alone for fully resectable stage III melanoma patients with either lymph node or skin metastases. The other arm was a prior treatment, prior to surgery, with four consecutive injections intratumorally, for the skin and lymph nodes with Daromun. I need to explain Daromun briefly because the agent is new. It's a composition of an L19 antibody directed to fibronectin, which is a crucial molecule for the development of neovascularization, particularly in tumors. And this is linked to interleukin 2, which enhances the number of tumor infiltrating lymphocyte in the tumor, and in addition to another antibody, which is linked to the drug, which is very important for the tumor necrosis, the tumor necrosis factor alpha. It's two component brought to one injection, and this has been done four consecutive times. The result of the study is that the primary endpoint, which is relapse three survival is positive. A positive randomized phase III trial and the hazard ratio is 0.59, corresponding to a more than 40% reduction of the risk for recurrence and the risk of death. Secondary endpoints as distant metastasis-free survival were also positive. In the same ballpark, the hazard ratio here is .60, so 40% reduction in the risk to develop distant metastases. I need to mention that there was a study amendment which allowed us to evaluate the tumor specimens, which have been treated by Daromun, and the rate of pathologically confirmed complete responses is 21%. Further read shots on this is following. Of note, there was almost no systemic toxicity. All of the toxicities were local. It was very well tolerated, it was manageable, and the mean number of administered cycles was three, the median number was four. Almost all patients got the full package of four injections. In general, I need to say and conclude, positive phase III trial, met the primary endpoint and it will be submitted primarily to the European medical agencies very soon and we will see what happens. But I hope that we will have a new drug in our treatment armamentarium for stage three melanoma patients with fully resectable disease in the neoadjuvant intention.

Related Videos

Breast Cancer

Denise A. Yardley, MD, on Early Breast Cancer: Findings From the NATALEE Trial on Patients With Node-Negative Disease

Denise A. Yardley, MD, of the Sarah Cannon Research Institute, discusses the NATALEE trial, which assessed ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs an NSAI alone in patients with hormone receptor–positive/HER2-negative early breast cancer at increased risk of recurrence, including patients with node-negative disease, and showed a benefit in invasive disease–free survival (Abstract 512).

Leukemia
Lymphoma

William G. Wierda, MD, PhD, on CLL/SLL: Updated Findings on Ibrutinib and Venetoclax

William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses up to 5.5 years of follow-up data from the phase II CAPTIVATE study, showing that in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), fixed duration ibrutinib plus venetoclax continues to provide clinically meaningful progression-free disease in those with high-risk genomic features as well as in the overall population (Abstract 7009).

Lymphoma

Peter Riedell, MD, on DLBCL: Expert Commentary on the DEB Study

Peter Riedell, MD, of The University of Chicago, discusses phase III results on the use of tucidinostat plus R-CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL) with double expression of MYC and BCL2. The regimen appeared to improve event-free survival and complete response rates vs R-CHOP in the front-line setting. As this is an interim analysis, longer-term follow-up will be needed to better understand its impact, says Dr. Riedell.

Issues in Oncology

Andrew Srisuwananukorn, MD, and Alexander T. Pearson, MD, PhD, on Artificial Intelligence in the Clinic: Understanding How to Use This 21st Century Tool

Andrew Srisuwananukorn, MD, of The Ohio State University, and Alexander T. Pearson, MD, PhD, of the University of Chicago, discuss the use of artificial intelligence (AI) in the clinic, its potential benefits in diagnosis and treatment, resources available to help physicians learn more about AI, and what’s coming for the next generation of medical school students.

Breast Cancer

Ciara C. O’Sullivan, MD, MBBCh, on HER2-Positive Breast Cancer: Expert Commentary on Treatments Under Study

Ciara C. O’Sullivan, MD, MBBCh, of Mayo Clinic, discusses three studies of treatment for patients with HER2-positive metastatic breast cancer and their clinical implications: the EMERALD trial of eribulin and taxane; the Patricia Cohort C trial of palbociclib plus trastuzumab and endocrine therapy; and DB07 on trastuzumab deruxtecan with or without palbociclib.

Advertisement

Advertisement




Advertisement