Knowledge present that the most cancers vaccine Cylembio plus Keytruda demonstrated scientific enchancment in progression-free survival in unresectable/superior melanoma.
Topline knowledge from a pivotal part 3 trial investigating the most cancers vaccine Cylembio (imsapepimut and etimupepimut, adjuvanted) plus Keytruda (pembrolizumab) in contrast with Keytruda alone in sufferers with unresectable or metastatic (superior) melanoma have been shared in a information launch from IO Biotech.
Though Cylembio (an investigational, immune-modulatory, off-the-shelf therapeutic) and Keytruda (an anti-PD-1 remedy) demonstrated scientific enchancment in progression-free survival, the mixture, evaluated throughout 407 sufferers, narrowly missed statistical significance for the first finish level.
“On this research, we noticed a extremely encouraging enchancment in progression-free survival and constant development in total survival in sufferers handled with Cylembio,” Dr. Mai-Britt Zocca, PhD, president and chief government officer of IO Biotech, mentioned “The magnitude and sturdiness of scientific impact noticed persistently throughout subgroups helps our confidence in Cylembio and its potential as a therapy for superior melanoma sufferers. We stay up for participating with the FDA to find out a possible path to approval primarily based on these knowledge.”
IO Biotech plans to satisfy with the U.S. Meals and Drug Administration (FDA) this fall, primarily based on the part 3 trial outcomes, in addition to current extra detailed outcomes from the IOB-013 research at an upcoming medical assembly. Notably, the assembly with the FDA will deal with figuring out subsequent steps for submission of a Biologics License Utility for the therapy of superior melanoma
Glossary
Medical Trial: Analysis research that take a look at new methods to stop, discover, or deal with illnesses like most cancers. They’re rigorously watched by medical doctors and comply with strict guidelines.
Full response: disappearance of all indicators of most cancers in response to therapy.
Median progression-free survival: time at which half of the research inhabitants has not skilled illness development.
Total response fee: the proportion of sufferers whose tumors shrink or disappear, together with each partial and full responses.
Total survival: time from therapy initiation till loss of life from any trigger.
Section 2 Trial: Exams a brand new therapy in a bigger group to see if it really works and to proceed checking its security.
Section 3 Trial: Compares a brand new therapy to the usual therapy in a really massive group of individuals to see if it is higher.
Development-free survival: time throughout and after therapy by which the illness doesn’t worsen.
Randomization: When folks in a scientific trial are assigned to totally different therapy teams by likelihood, like flipping a coin. This helps
Focused Remedy: Medicine that focus on particular options of most cancers cells, like sure genes or proteins, to cease their progress whereas usually inflicting much less hurt to wholesome cells.
Therapeutic Most cancers Vaccine Strategy Exhibits Profit in Superior Melanoma With Encouraging Survival Tendencies
Up to date findings from the part 3 research evaluating Cylembio together with Keytruda have been shared on August 11, 2025. Sufferers receiving the mixture remedy achieved an enchancment in progression-free survival in contrast with these handled with Keytruda alone, with a median progression-free survival of 19.4 months versus 11.0 months, respectively.
“On this research, sufferers handled with Cylembio together with Keytruda have achieved the longest median progression-free survival ever noticed in a part 3 scientific research in superior melanoma, and within the PD-L1 destructive inhabitants, sufferers achieved a outstanding 16.6 months of median progression-free survival, in comparison with 3.0 months in sufferers handled with Keytruda alone,” Dr. Omid Hamid, mentioned. “The numerous profit seen throughout sufferers with poor prognostic components, together with PD-L1 destructive sufferers, can’t be missed. Given the notable security profile and the robust scientific impact noticed with Cylembio, in addition to the unmet want in superior melanoma sufferers, Cylembio, if accepted, has the potential to grow to be a brand new commonplace of take care of sufferers with superior melanoma.”
Hamid is the director of Medical Analysis and Immunotherapy at The Angeles Clinic and Analysis Institute, A Cedars Sinai Affiliate.
Notably, in a subgroup of sufferers with out prior remedy (371 sufferers), Cylembio plus Keytruda achieved an enchancment in progression-free survival, with a median progression-free survival of 24.8 months in contrast with 11.0 months for the management arm. Enchancment in progression-free survival was noticed throughout practically all affected person subgroups, together with these with poor prognostic components.
Furthermore, sufferers with PD-L1–destructive tumors skilled a pronounced profit from the mixture remedy, with a median progression-free survival of 16.6 months versus 3.0 months for Keytruda alone.
A development towards improved total survival was additionally noticed with the mixture, though total survival knowledge are usually not but mature. The routine was effectively tolerated, with no new security alerts reported.
“These knowledge present the potential of a therapeutic most cancers vaccine in sufferers with metastatic melanoma,” Dr. Jessica Hassel, lead enrolling investigator for the part 3 trial, added within the information launch. “We have been thrilled to play such an essential half on this research and to have had the flexibility to supply our sufferers an investigational remedy that probably provides enhancements in PFS whereas not including vital systemic toxicity.”
Hassel can also be a professor on the Division of Dermatology and Nationwide Middle for Tumor Ailments on the College Hospital Heidelberg, Germany.
Extra Info on the Section 3 IOB-013/KN-D18 Trial in Superior Melanoma
The pivotal part 3 IOB-013/KN-D18 trial is an open-label, randomized research that enrolled 407 sufferers with beforehand untreated, unresectable, or metastatic melanoma throughout greater than 100 websites worldwide. Sufferers obtained both Cylembio plus Keytruda (203 sufferers) or Keytruda alone (204 sufferers), with progression-free survival as the first finish level.
Secondary endpoints embody total and sturdy response charges, full response fee, period of response, time to finish response, illness management fee, security, and tolerability.
Cylembio is a therapeutic most cancers vaccine designed to focus on and kill each tumor cells and immune-suppressive cells within the tumor microenvironment. IO Biotech is evaluating Cylembio in a number of research, together with:
- This part 3 investigation together with Keytruda versus Keytruda alone in superior melanoma
- The Section 2 IOB-022/KN-D38 basket trial as first-line therapy in superior stable tumors
- The Section 2 IOB-032/PN-E40 basket trial as neoadjuvant/adjuvant remedy for stable tumors.
In December 2023, enrollment for the part 3 trial was accomplished, and topline outcomes are anticipated to be reported within the third quarter of 2025; enrollment in each ongoing part 2 research at the moment are full.
“These knowledge present proof {that a} therapeutic most cancers vaccine can enhance development free survival in sufferers with metastatic illness,” Dr. Inge Marie Svane, principal investigator of the ohase 3 trial, added.
Svane is a professor and director of the Nationwide Middle for Most cancers Immune Remedy (CCIT) on the Copenhagen College Hospital, Herlev.
Reference
- “IO Biotech Publicizes Medical Enchancment in Development Free Survival Demonstrated in Pivotal Section 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Remedy of First-line Superior Melanoma, however Statistical Significance Narrowly Missed,” by IO Biotech. Information launch. Aug 11, 2025.
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