Immuno-Oncology Essentials

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.

02/28/2026

A “Behind the Paper” perspective on the phase 2 FMT-LUMINate trial highlights a key insight: response to immunotherapy may depend less on adding beneficial microbes and more on eliminating immunosuppressive bacterial taxa.

Responders demonstrated consistent loss of specific baseline bacteria (including Enterocloster, Streptococcus, and Clostridium spp.), associated with improved immune profiles and reduced immunosuppressive metabolism.

These findings suggest a shift in how we think about microbiome modulation in oncology.

F***l microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial - Nature Medicine

02/23/2026

In the phase 2 FMT-LUMINate trial (Nature Medicine, 2026), f***l microbiota transplantation (FMT) combined with immune checkpoint inhibitors demonstrated notable activity in first-line settings:

NSCLC: ORR 80% (anti–PD-1 + FMT)

Melanoma: ORR 75% (dual ICI + FMT)

FMT was well tolerated in NSCLC, with higher-grade adverse events consistent with dual ICI in melanoma. These findings support the potential role of microbiome modulation in overcoming primary resistance to immunotherapy.

In a phase 2 trial evaluating healthy donor f***l microbial transplantation plus either anti-PD-1 in patients with non-small cell lung cancer or anti-PD-1 and anti-CTLA-4 in patients with melanoma, encouraging efficacy was seen in both cohorts, with responses linked to significantly greater loss of....

02/09/2026

Iovance Therapeutics has reported real-world outcomes for commercial Amtagvi® (lifileucel) in previously treated advanced (unresectable or metastatic) melanoma.

In a retrospective analysis of 41 evaluable patients treated at four authorized U.S. centers, physician-assessed confirmed objective response rate (ORR) was 44% (18/41), with a 73% disease control rate (30/41). Outcomes appeared more favorable with earlier use: ORR was 52% (12/23) in patients receiving two or fewer prior lines of therapy versus 33% (6/18) after three or more lines. These real-world findings exceed the 31% ORR reported in the C-144-01 trial supporting accelerated FDA approval.

Amtagvi is the first FDA-approved T cell therapy for a solid tumor and is indicated for adults with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy when appropriate. Continued approval is contingent upon confirmatory evidence.

Full data were presented at the 2026 ASTCT®/CIBMTR® Tandem Meetings. Clinicians are encouraged to review the complete announcement and prescribing information, including safety considerations.

https://ir.iovance.com/news-releases/news-release-details/best-class-real-world-data-support-early-amtagvir-treatment

01/12/2026

AIM with Immunotherapy offers comprehensive Drug Management Toolkits to support healthcare providers in delivering safe and effective immunotherapy treatments. Each toolkit, available as a downloadable PDF, provides detailed guidance on drug dosing, administration, notable toxicities, and clinical insights.

Key features include:

Clear dosing and administration instructions
Strategies for managing side effects and toxicities
Expert clinical pearls and practical tips
FAQs to address common concerns
Resources for both clinicians and patients
Recommendations for monitoring, patient education, and follow-up care

These toolkits are designed to be practical references for daily clinical use, helping improve patient outcomes and support informed decision-making.

Explore and download the toolkits for each immunotherapy drug to enhance your practice and patient care.

https://aimwithimmunotherapy.org/provider-resources/healthcare-provider-toolkits/

01/09/2026

Liquid biopsies across the cancer care continuum: opportunities to address key challenges and to support the implementation of liquid biopsies throughout the cancer care continuum.

>>https://www.nature.com/articles/s41591-025-04093-9