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

2024 ASCO Annual Meeting


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).


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

Clifford A. Hudis, MD, and Karen E. Knudsen, MBA: An ASCO–American Cancer Society Partnership to Benefit Patients

Clifford A. Hudis, MD, CEO of the American Society of Clinical Oncology (ASCO), and Karen E. Knudsen, MBA, CEO of the American Cancer Society, discuss a newly launched collaboration between the organizations to make it simpler for patients to find authoritative cancer information online. The effort creates one of the largest and most comprehensive online resources for credible cancer information, available for free to the public on


Gynecologic Cancers

Katherine C. Fuh, MD, PhD, on Ovarian Cancer: New Data on Batiraxcept and Paclitaxel

Katherine C. Fuh, MD, PhD, of the University of California, San Francisco, discusses phase III findings of the AXLerate-OC trial, showing that batiraxcept with paclitaxel compared to paclitaxel alone improved progression-free and overall survival in patients with platinum-resistant recurrent ovarian cancer whose tumors were AXL-high in an exploratory analysis (LBA5515).

Multiple Myeloma

Luciano J. Costa, MD, PhD, on Multiple Myeloma: Subgroup Analysis of CARTITUDE-4 on Ciltacabtagene Autoleucel

Luciano J. Costa, MD, PhD, of the University of Alabama at Birmingham, discusses recent findings from the CARTITUDE-4 trial showing that, in patients with lenalidomide-refractory functional high-risk multiple myeloma after one prior line of treatment, ciltacabtagene autoleucel improved outcomes vs the standard of care (Abstract 7504).


Yasmin H. Karimi, MD, on Large B-Cell Lymphoma: Follow-up on Subcutaneous Epcoritamab Monotherapy

Yasmin H. Karimi, MD, of the University of Michigan Comprehensive Cancer Center, discusses 2.5-year follow-up data on epcoritamab monotherapy for patients with relapsed or refractory large B-cell lymphoma. The subcutaneous regimen continues to demonstrate durable responses (Abstract 7039).

Skin Cancer

Pauline Funchain, MD and Paolo A. Ascierto, MD, on Advanced Melanoma: Results From the RELATIVITY-048 Trial

Pauline Funchain, MD, of Stanford University and the Stanford Cancer Institute, and Paolo A. Ascierto, MD, of Italy’s Istituto Nazionale Tumori and IRCCS Fondazione G. Pascale, discuss efficacy and safety findings of the triplet therapy nivolumab, relatlimab-rmbw, and ipilimumab in patients with advanced melanoma (Abstract 9504).