Immuno-Oncology Essentials

10/01/2026

Gene expression profiling is evolving as an additional tool in melanoma risk assessment—but where might it fit into sentinel lymph node biopsy decision-making?

In this HCP education program from AIM, Vernon Sondak, MD, and Tina J. Hieken, MD, examine the evolving evidence for gene expression profiling in early-stage melanoma, including findings from the prospective MERLIN_001 study.

Through two clinical case studies, the discussion explores the potential role of GEP testing in predicting sentinel lymph node status, where it may provide additional information alongside established clinicopathologic factors, and important limitations and areas where further research is needed.

Explore the program and additional resources on genomic testing in melanoma.

Gene Expression Profile Testing in Melanoma Learn how gene expression profile testing in melanoma personalizes risk assessment and guides staging, surveillance, and shared decision-making. Overview Successful treatment decision-making for melanoma and other cancers is dependent…

09/23/2026

NEW TOOLKIT | Cosibelimab-ipdl (Unloxcyt™)

AIM has added a new Cosibelimab-ipdl Immunotherapy Drug Management Toolkit to our growing library of clinical resources for healthcare providers.

Cosibelimab-ipdl (Unloxcyt™) is a PD-L1–blocking antibody indicated for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for curative surgery or curative radiation therapy.

Designed as a practical resource for the clinical setting, the new toolkit includes:

• Drug dosing and administration
• Notable toxicities and management strategies
• Clinical pearls
• Frequently asked questions
• Patient and healthcare provider resources
• Additional guidance for monitoring, patient education and follow-up care

The toolkit is available as a downloadable PDF for easy online reference, printing and sharing with your clinical team.

Access the new Cosibelimab-ipdl toolkit: https://aimwithimmunotherapy.org/provider-resources/healthcare-provider-toolkits/

08/20/2026

Phase 3 Update | Resected Melanoma

Merck and Moderna have announced positive topline results from the Phase 3 INTerpath-001 trial evaluating intismeran autogene (V940) plus KEYTRUDA® (pembrolizumab) as adjuvant treatment for patients with completely resected stage IIB–IV melanoma.

At a pre-specified interim analysis, the combination demonstrated statistically significant and clinically meaningful improvements in recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) compared with pembrolizumab alone, meeting the study’s primary RFS endpoint and a key secondary DMFS endpoint.

Intismeran autogene is an investigational mRNA-based individualized neoantigen therapy designed based on the unique mutational profile of an individual patient's tumor.

Overall survival and other key secondary endpoints remain under evaluation. The companies reported that safety profiles were consistent with previous studies of the combination, with no new safety signals observed.

Complete Phase 3 data have not yet been presented and will be important for assessing the magnitude and durability of benefit, safety, and potential implications for the evolving adjuvant melanoma treatment landscape.

AIM With Immunotherapy will continue to follow the INTerpath-001 data as they are presented.

https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/

08/03/2026

Congratulations to our President, Samantha Guild, JD, recipient of the 2026 Tara Withington Public Service Award from the Society for Immunotherapy of Cancer (SITC) 🎉

This distinguished honor recognizes Sam's exceptional leadership, tireless advocacy, and unwavering commitment to the melanoma community. Through her vision and dedication at AIM at Melanoma, she has amplified the voices of patients, advanced critical research funding, and helped shape a more hopeful future for those affected by this disease.

Sam will be formally recognized during the SITC 2026 Annual Meeting, taking place November 4–8, 2026, at the Phoenix Convention Center in Arizona.

On behalf of our entire team, patients, families, and partners — congratulations, Sam. This recognition is a true testament to the profound impact of your service and leadership.

https://lnkd.in/g9w-b22S

04/10/2026

RP1 + nivolumab was not approved by the FDA for advanced melanoma.

The decision was based on concerns regarding the adequacy of the clinical trial design to demonstrate efficacy. No new safety signals were identified.

Additional studies are ongoing.

Details: https://www.aimatmelanoma.org/fda-does-not-approve-rp1-in-combination-with-nivolumab-for-advanced-melanoma-what-this-means-for-patients/

03/24/2026

A recent study looked at people with Stage IIB and IIC melanoma after surgery to understand how treatment with pembrolizumab may impact future skin cancer risk.

The findings showed that the risk of developing a new melanoma was similar whether or not patients received pembrolizumab. However, other types of skin cancer, like basal cell and squamous cell carcinoma, were more common in patients who did not receive the treatment.

Importantly, pembrolizumab was associated with a lower risk of melanoma returning. Side effects, including skin reactions, were reported but were generally infrequent and manageable.

https://ascopost.com/news/february-2026/stage-ii-melanoma-adjuvant-pembrolizumab-and-risk-of-new-skin-cancers/

03/16/2026

A new study published in Nature Medicine reports results from the phase 1b/2 Morpheus-Melanoma trial evaluating novel neoadjuvant immune checkpoint combinations in patients with resectable stage III melanoma.

The study examined tobemstomig, a PD-1/LAG-3 bispecific antibody, alone and in combination with tiragolumab, compared with the current combination of nivolumab plus ipilimumab.

Key findings include:
• Comparable pathological response rate with tobemstomig vs nivolumab + ipilimumab (80.0% vs 77.3%)
• Lower rates of grade ≥3 treatment-related adverse events with tobemstomig (2.5% vs 22.7%)
• No treatment discontinuations due to TRAEs in the tobemstomig arm (vs 13.6% with nivolumab + ipilimumab)

Read the full study:

In the randomized phase 1b/2 Morpheus-Melanoma trial evaluating various neoadjuvant immune checkpoint inhibitor regimens in patients with resectable stage III melanoma, tobemstomig, an anti-PD-1/anti-LAG-3 bispecific antibody, showed the highest pathologic response rate with a better safety profile....

03/13/2026

We’re proud to share new work published in the Journal for ImmunoTherapy of Cancer by experts from the Society for Immunotherapy of Cancer (SITC) — including AIM at Melanoma President Sam Guild, JD, as a co-author.

This paper explores an important and growing issue in cancer care: how to better monitor and manage delayed and chronic immune-related side effects that can occur after treatment with immune checkpoint inhibitors.

Immunotherapy has transformed outcomes for many patients with melanoma and other cancers, but these treatments can lead to side effects that may appear months or even years after therapy. The authors highlight the need for stronger long-term data, coordinated survivorship care, and improved monitoring to support patients throughout their cancer journey.

At AIM at Melanoma, advocating for patients and their families includes helping bring the patient perspective into scientific and clinical discussions that shape the future of cancer care.

We’re grateful to the experts and organizations working to improve survivorship care for people treated with immunotherapy.
Read the paper:
https://bit.ly/4sghLfC

03/12/2026

AIM with Immunotherapy has released a new Healthcare Provider Toolkit for Pembrolizumab and berahyaluronidase alfa-pmph, now available as a free PDF download.

This toolkit is designed to support oncology care teams with practical guidance for managing patients receiving this immunotherapy combination. It includes information on dosing, administration, indications across multiple cancer types, and key clinical considerations.

📄 Download the toolkit:
https://aimwithimmunotherapy.org/provider-resources/healthcare-provider-toolkits/

Resources like this help clinicians stay informed as new immunotherapy options continue to expand for patients with melanoma and many other cancers.

03/02/2026

In a secondary analysis of the phase 3 KEYNOTE-716 trial (JAMA Network Open, 2026), adjuvant pembrolizumab in resected stage IIB/IIC melanoma was not associated with an increased risk of new primary melanoma compared with placebo.

Nonmelanoma skin cancers were more frequent in the placebo arm, and recurrence-free survival benefit with pembrolizumab was maintained after accounting for new primary melanomas.

These findings support the continued use of adjuvant pembrolizumab in high-risk stage II melanoma.

This secondary analysis of a randomized clinical trial assesses new skin cancers, recurrence-free survival with new melanomas considered events, and immune-mediated severe skin reactions among patients receiving pembrolizumab or placebo for stage II melanoma.