ESMO Congress 2026

Moderna’s melanoma vaccine data bring adoption test into focus

Moderna's personalized cancer vaccine intismeran autogene combined with Keytruda reduced the risk of recurrence or death by 42% in a Phase III melanoma trial (HR=0.58, p<0.001), validating the benefit of personalized vaccines in adjuvant therapy. But the therapy faces challenges from personalized manufacturing complexity, high costs and competition from neoadjuvant immunotherapy strategies, and the trial did not directly compare against neoadjuvant regimens, so commercial adoption remains to be weighed.

Detailed Phase 3 Data for intismeran autogene Plus Keytruda in Melanoma Show 42% Lower Recurrence or Death Risk

Merck and Moderna have announced detailed Phase 3 results for the personalized mRNA cancer therapy intismeran autogene combined with Keytruda (pembrolizumab) in melanoma. Compared with Keytruda alone, the combination reduced the risk of disease recurrence or death by 42%.

The benifit is same as if you give neo adjuvant pembrolizumab? - cross trial comparisons- Will this hold true if Pembrolizumab is given neoadjuvant in control arm ? We don't know…

FDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication

The FDA has converted the indication for pembrolizumab in unresectable or metastatic TMB-H solid tumors to traditional approval, with TMB-H now defined as ≥13 mut/Mb.

Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer

Immune Checkpoint Blockade and Chemotherapy With or Without Fecal Microbiota Transplant in Advanced Non-Small Cell Lung Cancer

Optimizing Response to Immunotherapy With Online Adaptive Pulsed Radiotherapy in Incurable Head and Neck Cancers

Pulsed Stereotactic Ablative Radiotherapy (PULSAR) With Systematic Therapy for Thyroid Cancer

Neoadjuvant Pembrolizumab in Patients With High Risk, Stage IIB/IIC Cutaneous Melanoma: a Single Arm Proof of Concept Phase IIA Study.

#ESMO26 | PERSEE – Phase III In advanced NSCLC with PD-L1 ≥50%, adding chemotherapy to pembrolizumab improved median PFS from 6.9 to 16.1 months (HR 0.56). The numerical OS differ…

A BRCA1 Carrier's Genetic Screening, Preventive Surgery and Pregnancy Breast Cancer Journey

BRCA1 carrier Carolyn Searles underwent a preventive bilateral mastectomy in November 2021, yet was diagnosed with breast cancer at 16 weeks of pregnancy in 2025. She received chemotherapy during pregnancy, delivered at 33 weeks and 4 days, added pembrolizumab after giving birth, and an MRI after her final chemotherapy showed no signs of cancer; she is now in remission. She urges anyone with a family history to get genetic testing.

ESMO 2026: 15 Trials That May Change Treatment Practice

Does the Disease-free Survival Benefit of Adding Belzutifan to Adjuvant Pembrolizumab Persist Beyond the Planned Treatment Period? A Reconstructed Individual Patient Data Analysis of Phase 3 Renal Cell Carcinoma Trials

The DFS benefit of adding belzutifan to adjuvant pembrolizumab in LITESPARK-022 attenuates after treatment ends, a reconstructed individual patient data analysis of ten phase 3 adjuvant renal cell carcinoma trials finds. The hazard ratio was 0.55 (0.43-0.71) before month 12 but 1.16 (0.87-1.54) afterwards, a post/pre ratio of 2.10, matching trials whose benefit faded (SORCE, PROTECT) rather than KEYNOTE-564, where it persisted. The 24-month restricted mean survival time difference was 1.34 months (0.73-1.95), and durability of the absolute advantage is uncertain, so single-HR projections should be avoided.

Other | Cancer Accelerated Approvals

FDA granted traditional approval on 10/16/2026 to Keytruda Qvantig... correction: Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for adults and patients 12 years and older with unresectable or metastatic TMB-H (≥10 mut/Mb) solid tumors, as determined by an FDA-approved test, that progressed after prior treatment with no satisfactory alternative options. The accelerated approval for this formulation was filed 9/19/2025. Separately, Lunsumio Velo (mosunetuzumab-axgb) for relapsed or refractory follicular lymphoma after two or more systemic lines, filed 12/19/2025, remains ongoing, as do three Brukinsa (zanubrutinib) accelerated approvals dated 6/10/2025 covering MCL, MZL and FL with obinutuzumab.

Verified Clinical Benefit | Cancer Accelerated Approvals

The FDA lists oncology accelerated approvals that have since had clinical benefit verified, spanning drugs from Keytruda and Opdivo to Tecvayli and Imdelltra. Each entry pairs the original accelerated approval date with its verification date, for example Keytruda in TMB-high solid tumors and Breyanzi in relapsed or refractory follicular lymphoma. The list covers indications across solid tumors and blood cancers, including Retevmo in RET fusion solid tumors, Tecvayli in multiple myeloma and Jaypirca in CLL/SLL.

PD-1 Blockade Alone Versus in Combination With Chemotherapy as First Line Therapy in Females With Advanced NSCLC & PD-L1 Expression ≥50%

A Clinical Trial Comparing an Antibody (INCA33890) Versus Pembrolizumab for Squamous Cell Carcinoma of the Head and Neck.

BNT113 Plus Pembrolizumab Misses PFS Endpoint in HPV16-Positive Head and Neck Cancer Trial

BioNTech's mRNA cancer immunotherapy candidate BNT113, combined with pembrolizumab, failed to significantly improve progression-free survival compared with pembrolizumab alone in patients with metastatic HPV16-positive head and neck cancer, missing the first dual primary endpoint of the phase II/III AHEAD-MERIT trial. The trial continues to assess overall survival, the second dual primary endpoint.

FDA Accepts First US Filing for Pembrolizumab Biosimilar FYB20 from Formycon and Zydus

The FDA has accepted for review the marketing application for FYB20, a biosimilar of pembrolizumab developed by Formycon, which filed the submission jointly with Zydus. It is the first pembrolizumab biosimilar submitted for approval in the US. Formycon licensed FYB20 rights for the US and Canada to Zydus and for the Middle East and North Africa to MS Pharma in December 2025, and Asia-Pacific rights to Lotus Pharmaceutical in February 2026.

BioNTech BNT113 Plus Pembrolizumab Misses PFS Endpoint in AHEAD-MERIT HPV16-Positive HNSCC Trial

BNT113 plus pembrolizumab failed to significantly improve progression-free survival versus pembrolizumab alone in first-line HPV16-positive head and neck squamous cell carcinoma, according to first topline results from the phase 2/3 AHEAD-MERIT trial (NCT04534205). PFS was a dual primary endpoint. BNT113 is an mRNA tumor immunotherapy encoding the HPV16 E6 and E7 proteins.

BioNTech BNT113 Plus Pembrolizumab Misses PFS Endpoint in Head and Neck Cancer Trial

The AHEAD-MERIT phase 2/3 trial found that the mRNA cancer immunotherapy candidate BNT113 plus pembrolizumab did not improve progression-free survival versus pembrolizumab alone in metastatic HPV16-positive head and neck cancer, missing the first dual primary endpoint. The trial continues to assess the second dual primary endpoint, overall survival.

A Study to Learn the Safety and Efficacy of HLX37 in Combination With Chemotherapy for First-line Treatment in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

US/PA/E Imaging for Early Identification of Tumor Response in Patients With Stage II-III Triple Negative Breast Cancer Receiving Neoadjuvant Immunotherapy and Chemotherapy

Labyrinthin Vaccination in Veterans With Lung Adenocarcinoma

Reduction of Neoadjuvant Treatment in Early Triple-Negative Breast Cancer

Once yearly cell-based therapy for sustained and dose-tunable delivery of monoclonal antibodies.

An encapsulated cell-based "biologics factory" using an immunomodulatory alginate formulation sustained stable serum titers of the HIV-neutralizing mAb 3BNC117 for 1 year in immunocompetent mice, supported by an anti-inflammatory, proresolving immune niche that attenuates fibrosis. The platform produced 13 diverse mAbs from an allogeneic cell chassis, and in a nonhuman primate subcutaneous implant maintained stable ipilimumab titers for more than 6 months with no detectable toxicity, antidrug antibodies, or adverse events across a three-dose escalation. A retrievable macrodevice allows on-demand termination and dose-proportional tuning, pointing toward replacing frequent injections with single-administration therapy.

Adjuvant Pembrolizumab plus Belzutifan for Renal-Cell Carcinoma

The New England Journal of Medicine on October 1, 2026 (Volume 395, Issue 13, pages 1347-1348) published a short piece on adjuvant pembrolizumab plus belzutifan for renal-cell carcinoma. The original contains bibliographic information only; the text provides no trial name, sample size, endpoints, or response rates that can be verified.

NMPA Approves Subcutaneous Pembrolizumab, First of Its Kind in China

China's NMPA has approved Merck's subcutaneous formulation of the PD-1 inhibitor pembrolizumab, covering 19 solid tumour indications, making it the first and currently only subcutaneous PD-1 inhibitor approved in China. The approval, announced on 29 September 2026, is based on data from study MK-3475A-D77. The approval covers the same indication set as the existing intravenous formulation.

NMPA Approves MSD's Subcutaneous Pembrolizumab MK-3475A in China

China's NMPA approved MSD's subcutaneous pembrolizumab injection (MK-3475A) on September 28, per the agency's website. The formulation, known as a subcutaneous version of Keytruda, had already been approved by the US FDA in September 2025 as Keytruda QLEX and in the EU in November 2025. The approval gives pembrolizumab a new route of administration in China.

Tissue resident CD4+ memory T-cells mark response to immune checkpoint inhibition in high-grade glioma

Tissue-resident CD4+ memory T cells mark which high-grade gliomas respond to combined PD-1 and CTLA-4 inhibition. In a syngeneic hypermutated glioma model, response involved clonal expansion of tumor-reactive cytotoxic T cells and infiltration of CXCR6+ CD4+ Trm cells, with CD4 stem-like memory cells showing interferon responses rather than exhaustion. In IDH1 wildtype glioblastoma patients treated with neoadjuvant pembrolizumab, CD4+ Trm association with prolonged overall survival was confirmed.