ESMO 2026
Data Presentations
Last updated: November 3rd 2026
This is a selection of materials from the ESMO congress. If you’re interested in additional BMS content, please don’t hesitate to get in touch.
Three-year distant metastasis-free survival of the phase 3 NADINA trial comparing neoadjuvant nivolumab plus ipilimumab versus adjuvant nivolumab in resectable stage III melanoma
Key takeaways
- Neoadjuvant therapy remained superior at 3 years. Median follow-up was 36 months. 3-year EFS was 72.9% vs 50.0% (HR 0.42; 95% CI 0.31-0.59; p<0.0001). 3-year DMFS was 75.3% vs 57.4% (HR 0.46; p<0.0001).
- The benefit was consistent regardless of BRAF mutation status (BRAF V600E/K vs wildtype/other).
- pCR was associated with excellent outcomes without adjuvant therapy. Among patients with pCR, 3-year RFS was 91.3% and 3-year DMFS 93.6%.
- Outcomes in near-pCR patients were worse than in earlier analyses. 3-year RFS was 62.3% and DMFS 69.3%, with small numbers at risk. Patients with pathological non-response (pNR) had the poorest outcomes (3-year RFS 43.0%, DMFS 39.4%).
- The value of adjuvant therapy after non-MPR remains debatable. The presenters concluded that adjuvant treatment (dabrafenib + trametinib or nivolumab) seemed not to add clear clinical benefit in these patients. This is a subgroup observation, not a randomized comparison.
Key takeaways
- Nationwide Norwegian registry data from 36,687 patients demonstrate significantly improved 3-year overall survival (OS) for stage III and stage IV melanoma. OS remained stable for stage I and II disease.
- These findings are consistent with the introduction of effective systemic therapies for stage III and IV melanoma.
Key takeaways
- A total of 1,394 patients were included, comprising 1,032 patients with ocular melanoma and 362 patients with mucosal melanoma.
- Longer survival with ICI, compared to chemotherapy, was observed in the mucosal melanoma cohort but not in the ocular melanoma cohort.
- Mucosal melanoma survival differed by primary site, reflecting biological heterogeneity, while ocular melanoma survival remained limited regardless of treatment. Findings underscore the need for improved therapeutic strategies.
Resistance to PD-1 Blockade in Advanced Melanoma: Clinical and Translational Analyses in PD-L1 Subgroups from RELATIVITY-047
Key takeaways
- Time course of benefit differed by PD-L1 status. With nivolumab + relatlimab, PFS benefit was seen in PD-L1 <1% (HR 0.60; 95% CI 0.47–0.75) but not PD-L1 ≥1% (HR 0.95; 95% CI 0.70–1.30), where OS separation emerged at approximately 3 years.
- In PD-L1 ≥1%, the OS difference appeared to arise after progression. The post-progression HR was 0.71 (95% CI 0.49–1.04).
- LAG-3 may contribute to PD-1 resistance. In PD-L1 ≥1% patients on nivolumab alone, high baseline peripheral LAG-3⁺ CD8 T cells were associated with shorter OS. This was not seen with nivolumab + relatlimab.
- Fewer tumors showed primary resistance with the combination. Primary resistance was 38% vs 50% in PD-L1 ≥1% and 53% vs 67% in PD-L1 <1% (nivolumab + relatlimab vs nivolumab).
- Interpret with caution. These were exploratory, post hoc analyses in small subgroups, and some confidence intervals include 1. The findings are hypothesis-generating.
Adjuvant nivolumab for resected stage III–IV melanoma in France: 4-year data and age group analyses from AdjuMel
Key takeaways
- Real-world outcomes with adjuvant nivolumab in resected stage III-IV melanoma. In 350 patients from France (median follow-up 47.3 months), the 4-year RFS rate was 44.3% (95% CI 38.7-49.7) and the 4-year DMFS rate was 54.6% (95% CI 48.9-60.0). The authors describe these results as consistent with those of CheckMate 238.
- Outcomes were less favourable in patients aged ≥75 years (n=88). The 4-year RFS rate was 31.3% vs 48.5% in patients <75 years, and the 4-year DMFS rate was 41.1% vs 59.0%. Age ≥75 years was associated with a higher risk of distant metastasis or death (HR 1.46; 95% CI 1.02-2.10).
- The older group differed at baseline. More patients ≥75 years had comorbidities (68.2% vs 42.7%) and stage IIIC-IIID disease. They also received fewer nivolumab cycles and had a shorter treatment duration.
- Safety was manageable in both age groups. Grade 3-4 treatment-related AEs occurred in 10.2% of patients ≥75 years and 14.1% of those <75 years. Grade 3-4 treatment-related AEs leading to discontinuation occurred in 1.1% and 3.4%, respectively.
- Interpret with caution. This is an observational study without a comparator. The age-group comparisons were not adjusted for baseline differences, the ≥75 group was small, and some patients were lost to follow-up.
Real-world outcomes among patients with resectable stage III melanoma treated with neoadjuvant nivolumab + relatlimab or nivolumab + ipilimumab in the US
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Key takeaways
- Real-world evidence for neoadjuvant dual checkpoint blockade. This retrospective study of 100 patients (50 per arm) adds US real-world data on nivo+rela and nivo+ipi in resectable stage III melanoma.
- Similar outcomes despite a sicker nivo+rela cohort. The nivo+rela patients had less favourable baseline characteristics, including more ECOG ≥2 and higher LDH. Unadjusted 9-month EFS and DMFS were still numerically similar (EFS 92.0% vs 91.1%; DMFS 93.3% vs 94.6%).
- Trend favouring nivo+rela after adjustment. IPTW-adjusted analyses showed a trend toward higher pCR (39.8% vs 26.0%) and numerically higher 9-month EFS (93.2% vs 83.3%) and DMFS (96.1% vs 85.5%) with nivo+rela.
- Pathologic response tracks outcome. Patients with MPR had 98.5% 9-month EFS, DMFS and OS, vs 80.9% EFS and 85.7% DMFS in non-MPR.
Impact of BRAF V600K mutation in patients with resectable stage III melanoma: a subgroup analysis of the NADINA trial
Key takeaways
Despite a worse baseline clinical profile, pts harboring BRAF V600K mut melanoma show higher pathological response rates upon neoadj IPI+NIVO, with 3-year EFS, RFS and DMFS rates comparable to V600E in both cohorts of the NADINA trial.
Final overall survival results from CheckMate 8HW: nivolumab plus ipilimumab vs nivolumab or chemotherapy in MSI-H/dMMR metastatic colorectal cancer
Key takeaways
- Nivo+ipi significantly improved OS vs nivo across all lines. HR 0.61 (95% CI 0.46–0.82; p=0.0009), 5-year OS 74% vs 62%. Median follow-up was 68.1 months.
- In 1L, nivo+ipi was superior to chemo on OS. HR 0.37 (0.24–0.57), 5-year OS 77% vs 46%, despite 80% of chemo-treated patients having received subsequent immunotherapy.
- In 1L, nivo+ipi vs nivo favoured the combination (HR 0.66; 0.44–0.99; 5-year OS 77% vs 66%), while missing the strict prespecified significance threshold as a final secondary analysis (p=0.0432 vs 0.0058).
- 1L ORR was 74% vs 61% (nivo) vs 27% (chemo). CR rates were 41%, 32% and 7%.
- Safety was consistent with earlier reports, with no new signals. Grade 3–4 TRAEs were 22% (nivo+ipi), 14% (nivo) and 51% (chemo).
Shift in treatment patterns and outcomes in metastatic colorectal cancer: A national Norwegian real-world study
Key takeaways
- Marked improval in overall survival for MSI-H metastatic colorectal cancer (mCRC) treated with immune checkpoint inhibitors (ICIs) was observed compared to MSI-H mCRC treated with other systemic anti-cancer therapies (SACT): median OS of 62.4 vs 10.5 months and 3-year OS of 59.3% vs 30.5% (ICI vs other SACT). The adjusted HR was 0.50 (95% CI 0.30–0.84).
- Improvements in SACT outcomes for the MSS mCRC phenotype remain warranted.
- These findings illustrate a shift in real-world outcomes in MSI-H mCRC with the advent of precision medicine and immunotherapy.
Biomarker signals in MSS/pMMR metastatic colorectal cancer (mCRC) are predominantly prognostic, not predictive. Lessons from the randomized METIMMOX trial
Key takeaways
In this exploratory analysis, biomarker signals in MSS/pMMR mCRC were predominantly prognostic rather than predictive.
The CRP × treatment interaction for PFS is hypothesis-generating, and evaluation in adequately powered prospective studies could be considered.
Self-perceived global health status as a prognostic factor for progression-free survival (PFS): a preplanned secondary analysis of the METIMMOX trial in metastatic microsatellite-stable (MSS) colorectal cancer (CRC)
Key takeaways
Baseline self-perceived global health status was an independent prognostic factor for PFS in first-line treatment of metastatic MSS CRC, even after adjusting for systemic inflammation.
This suggests that how patients perceive their health may matter as much as symptoms, functioning, and biological CRC markers when refining prognostic assessment.
Clinical, radiological, and molecular indicators of outcome in metastatic microsatellite-stable (MSS) colorectal cancer (CRC) treated with first-line oxaliplatin-based chemotherapy and nivolumab
Key takeaways
The METIMMOX regimen was highly effective for limited liver or lymph node metastases from right-sided MSS CRC but ineffective for peritoneal and lung metastases.
Radiologic biomarker-guided selection for first-line oxaliplatin-based chemotherapy and nivolumab in metastatic MSS/pmmr colorectal cancer (CRC): preliminary METIMMOX-2 results
Key takeaways
An early, pragmatic biomarker (≥10% TLR) may enrich patients with abdominal metastases from MSS/pMMR CRC for clinical benefit from the METIMMOX regimen.
However, too early baseline CT timing could underestimate TLR and risk misclassifying patients who might benefit.
Key takeaways
Neoadjuvant NIVO/IL-8 and NIVO/RELA showed limited efficacy in non-metastatic pMMR colon cancer, with a pathological response rate of 8% and 6%, respectively.
These results do not warrant further investigation of these combinations in the neoadjuvant setting.
Genomic alterations (GA) and association with post-surgery circulating tumor DNA (ctDNA) status in early-stage colon cancer (CC)
Key takeaways
- Actionable alterations: 67% of MSS tumors carry an actionable alteration at any level, and 13% carry a Level A alteration.
- ctDNA positivity: 13% of the patients were ctDNA-positive after surgery, similar in MSI-H and MSS. Higher in PIK3CA/PTEN-mutated MSS tumors (29% vs 12%).
- Integration of CGP and ctDNA: ctDNA flags residual disease and CGP supplies options: 68% of ctDNA-positive MSS patients had an actionable alteration (15% Level A).
ctDNA negativity influences adjuvant treatment decisions: a paired counterfactual analysis from the SAGITTARIUS trial
Key takeaways
- Impact on treatment intensity: ctDNA negativity shifted indication in the physician choice arm toward de-escalation.
- Impact on oxaliplatin exposure: ctDNA negativity increased oxaliplatin-free regimen allocation.
- Impacting features beyond ctDNA negativity: Higher age and lower stage were more associated with de-escalation.
ctDNA-guided adjuvant trials may miss the MRD window: evidence of early attrition during trial allocation
Key takeaways
- Early clinical relapse: 6% of screened population were found to have early clinical relapse accounting for ~ half of all screen failures.
- Timeline misalignment: A prolonged staging-to-randomization interval impacts radiological evidence of metastases.
- MRD window: Progression to overt metastatic disease was the leading cause of screening failure within the MRD window, about 2.5 times more frequent than test failure/delay (44% vs 18%).
Cost-effectiveness of a dynamic ctDNA-guided adjuvant strategy in stage II-III colon cancer. A SAGITTARIUS model-based analysis
Key takeaways
- ctDNA-positive patients: Early treatment adaptation in molecularly persistent disease generates substantial modelled survival and quality of life gains. Higher treatment costs are partly offset by lower relapse costs.
- ctDNA-negative patients: The modest QALY gain mainly reflects reduced treatment-related toxicity. Relapse rates remain similar.
- Under the modeled assumptions, dynamic ctDNA-guided management may be cost-effective in both postoperative ctDNA-positive and ctDNA-negative populations. Prospective evidence is needed to validate the assumed clinical benefits.
ROSETTA Gastric-204: a randomized, phase 2/3 study of first-line (1L) pumitamig + chemotherapy versus nivolumab (NIVO) + chemotherapy in advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC), or esophageal adenocarcinoma (EAC)
Key takeaways
Rationale: Many patients with HER2-negative GC/GEJC/EAC still progress on 1L PD-1 inhibitor + chemo, especially with low or negative PD-L1. Pumitamig is an investigational PD-L1 × VEGF-A bispecific designed to concentrate dual blockade in the tumor microenvironment.
Design: Seamless, blinded, randomized phase 2/3 trial (N = 690). Phase 2 selects the pumitamig dose (primary endpoint ORR). Phase 3 compares pumitamig + FOLFOX/CAPOX with nivolumab + FOLFOX/CAPOX in PD-L1 ≥1 patients, with PFS (BICR) and OS as dual primary endpoints.
Status: 101 of 161 planned sites were activated across 15 countries as of October 2, 2026.
Real-world outcomes of first-line nivolumab (NIVO) plus chemotherapy for HER2-negative metastatic gastric and gastroesophageal adenocarcinoma (GEAC)
Key takeaways
- Longer OS after 1st-line nivolumab + doublet chemotherapy vs. doublet chemotherapy alone, in a nationwide real-world practice cohort.
- While real-world OS rates were lower than CM649, relative survival (HR) and absolute survival differences are similar.
- High PD-L1 testing uptake in the Netherlands (92.9%)
Real-world outcomes of adjuvant nivolumab (NIVO) in patients with oesophageal (OC) and gastroesophageal junction cancer (GOJC) after neoadjuvant chemoradiotherapy and surgical resection
Key takeaways
- Real-world adjuvant nivolumab showed outcomes consistent with CM577: Median DFS of 34.7 months (CM577: 21.8 months), 1-year OS 89.3% (CM577: 85%), 2-year OS 70.9% (CM577: 68%).
- However, comparing trial with real-world results remains difficult, due to differences in patient population, follow-up duration, and in possible treatment after progression
- More favourable outcomes were observed in patients meeting CM577 eligibility criteria
Expanded Safety and Efficacy of Givastomig, a Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in 1L Metastatic Gastroesophageal Carcinoma (mGEC)
Key takeaways
- With longer follow-up, givastomig 8 mg/kg plus nivolumab and mFOLFOX6 showed encouraging and durable clinical activity across CLDN18.2 and PD-L1 subgroups. The manageable safety profile supports 8 mg/kg for Phase 3 development in 1L metastatic GEA.
- The overall AE profile is generally similar to IO/chemo alone, and immune-related AE rates do not appear increased over nivolumab + chemo in other studies, except for gastritis.
- Gastritis was manageable, with rare grade 3 events and no grade 4 or 5 events at 8 mg/kg. Follow-up continues, as does enrollment in CLDN18.2-positive pancreatic and biliary tract cancer cohorts.
Nivolumab + chemotherapy in patients with advanced upper gastrointestinal (or "esogastric") cancers in France: METAGIO study design and baseline characteristics
Key takeaways
- Patients enrolled in this prospective French real-world study reflect the broader and more clinically complex population encountered in routine practice. Patients are older and have poorer performance status than those included in CheckMate 649 and CheckMate 648.
- METAGIO provides an early characterization of patients receiving 1L nivolumab + CT in routine French clinical practice and highlights differences between real-world patients and those enrolled in CheckMate 649 and CheckMate 648 studies.
- METAGIO may provide valuable real-world evidence on clinical outcomes and treatment patterns in patients receiving nivolumab-based therapy for advanced upper gastrointestinal cancers, thereby helping to assess the generalizability of findings from pivotal clinical trials.
Prevalence, prognosis, and impact on tumor microenvironment of homozygous MTAP deletion in advanced solid tumors
Key takeaways
- MTAP-del was common across advanced solid tumors in treatment-naive phase 3 trial patients, with prevalence ranging from 7% (GC/GEJC/EAC) to 50% (MGMT-unmethylated GBM). It was numerically lower in PD-L1–positive tumors.
- MTAP-del tumors generally had numerically worse OS (HR > 1.00) and a colder TME than tumors without MTAP-del. IFN cluster co-deletion did not appear to drive the cold TME.
- The results reinforce an unmet need in MTAP-del tumors and support investigating novel regimens, such as navlimetostat (MTA-cooperative PRMT5 inhibitor) in the phase 2 MountainTAP-5 trial (NCT07492680).
A Phase II Study Evaluating BMS-986504 and chemotherapy in borderline resectable (cohort 1), locally advanced (cohort 2), and metastatic (cohort 3) MTAP-deleted Pancreatic Cancer
Key takeaways
- MTAP deletion occurs in about 20–25% of PDAC and increases reliance on PRMT5. Navlimetostat, an oral MTA-cooperative PRMT5 inhibitor, showed activity in preclinical PDAC models, alone and with chemo.
- This multicenter phase 2 trial (NCT07283705) has three cohorts of 20 patients: resectable/borderline resectable and locally advanced (gemcitabine/nab-paclitaxel + navlimetostat), and 1L metastatic (mFOLFIRINOX + navlimetostat).
- Primary endpoints are safety and tolerability in all cohorts, pathological response in Cohort 1, and 6-month PFS in Cohorts 2 and 3.
PRIMUS-001: An adaptive phase 2 study of FOLFOX-A (FOLFOX / nab-paclitaxel) versus AG (nab-paclitaxel / gemcitabine) in patients with metastatic pancreatic cancer, with biomarker evaluation
Key takeaways
A modest PFS benefit was observed in FOLFOX-A compared to AG in an unselected patient population. Patients with HRD tumours preferentially respond to FOLFOX-A, which can be a less toxic alternative to FFX. We demonstrated large scale tumour and liquid biopsy and molecular profiling is feasible.
A phase 1/2 trial of first-line pumitamig monotherapy or pumitamig plus ipilimumab in advanced or unresectable hepatocellular carcinoma (HCC) (ROSETTA HCC-206)
Key takeaways
- Rationale: HCC outcomes remain suboptimal despite dual checkpoint inhibitor therapy, so more 1L options are needed. Pumitamig is an investigational PD-L1 × VEGF-A bispecific designed to concentrate dual blockade in the tumor microenvironment.
- Design: Global, randomized, open-label phase 1/2 trial (NCT07291076, estimated N = 198) in previously untreated, locally advanced or unresectable HCC. Phase 1 is a safety lead-in of pumitamig + ipilimumab across four cohorts. Phase 2 randomizes patients to pumitamig at the recommended phase 2 dose, with or without ipilimumab.
- Endpoints: The phase 1 primary endpoint is safety and tolerability. The phase 2 primary endpoint is ORR by RECIST v1.1 per investigator. Secondary endpoints are safety, PK, ADA, PFS and DOR.
Randomized phase III study of izalontamab brengitecan (iza-bren) versus platinum-based chemotherapy in patients with EGFR-mutant nonsquamous non-small cell lung cancer previously treated with EGFR TKI
Key takeaways
- Iza-bren demonstrated a statistically significant and clinically meaningful improvement in PFS vs PBC in patients with EGFR-mutant non-squamous NSCLC after progression on a 3rd generation EGFR TKI (median PFS by BICR 11.1 vs 5.7 months; HR 0.40, 95% CI 0.31–0.51; p<0.0001).
- At this interim analysis, OS remained immature and a trend towards OS improvement with iza-bren was observed (median NR vs 19.4 months; 18-month OS 68.8% vs 55.3%).
- Iza-bren demonstrated an improved response rate with durable response vs. PBC (confirmed ORR 60.2% vs 34.5%; median DoR 10.4 vs 5.7 months).
- The safety profile of iza-bren was manageable and consistent with previous studies (grade ≥3 TRAEs 78.7% vs 62.1%; discontinuation due to TRAEs 1.9% in both arms; treatment-related ILD 0.9%).
A global phase 2, open-label trial of second-line pumitamig (PD-L1 x VEGF A bsAb) plus docetaxel in metastatic NSCLC: first data from the ROSETTA Lung-107 trial
Key takeaways
- Pumitamig plus docetaxel showed encouraging antitumor activity in patients with mNSCLC following progression on prior chemoimmunotherapy (cORR 36.7%, uORR 43.3% in response-evaluable patients, n = 30, with responses across PD-L1 expression levels and histologies).
- Early PFS data were encouraging, at 12.2 weeks median follow-up (median PFS 6.9 months, 6-month PFS rate 63.3%).
- Pumitamig plus docetaxel showed a manageable safety profile, with no new safety signals (grade ≥3 TRAEs 18%, no TRAE-related deaths). Bleeding events occurred in 16% of patients and were limited to grade 1 severity.
- Pumitamig is currently being evaluated in 4 phase 3 global studies in thoracic tumors, including 1L NSCLC, post-cCRT consolidation in unresectable NSCLC, and 1L SCLC. These first data support further investigation of pumitamig in patients with mNSCLC who have received a prior IO-containing regimen.
Phase II study of izalontamab brengitecan (iza-bren) combo with osimertinib in EGFR mutated locally advanced or metastatic NSCLC patients
Key takeaways
- With updated 2-year follow-up, iza-bren plus osimertinib continued to demonstrate promising and durable anti-tumor activity with a manageable safety profile in first-line EGFRmt NSCLC patients, supporting further development of the combination in this population. At 2.5 mg/kg (n=40), ORR was 100% and confirmed ORR 97.5%. Median DOR and PFS were not reached, and the 24-month PFS rate was 87.0%. Grade ≥3 TRAEs were 82.5% (mainly hematologic), and treatment-related ILD occurred in 1.3% overall (2 cases, both at 2.2 mg/kg).
- The 2.5 mg/kg D1D8 Q3W was chosen as the RP3D for combination treatment.
- The phase III study is ongoing in China (NCT06838273), and a global registrational study in first-line setting is ongoing (BMS IZABREN-LUNG02, NCT07680790).
INSIGHT PL: Real-world outcomes and clinical determinants with first-line nivolumab plus ipilimumab and chemotherapy in advanced NSCLC
Key takeaways
- First-line nivolumab plus ipilimumab combined with chemotherapy demonstrated clinically meaningful real-world effectiveness in patients with advanced/metastatic NSCLC (n=240; ORR 42.1%, DCR 73.8%, median DoR 12.5 months; median PFS 8.0 months, median OS 13.9 months).
- Baseline metastatic burden, ECOG performance status and NLR were independently associated with clinical outcomes (OS: >1 metastatic site HR 1.71, ECOG 1 vs 0 HR 2.09, NLR per 1-unit increase HR 1.04).
- Readily available baseline clinical characteristics may support risk stratification and individualized treatment decision-making in routine clinical practice.
Special situations in neoadjuvant nivolumab plus chemotherapy for resectable NSCLC: A subgroup analysis from a French multicenter study
Key takeaways
- pCR rate was lower in patients aged ≥70 years vs. <70 years, yet encouraging pathological responses were nonetheless observed. The high surgical resection rate in this subgroup further supports the feasibility of neoadjuvant nivolumab + chemotherapy in routine clinical practice.
- pCR appeared to discriminate outcomes more strongly than baseline disease stage, which supports pCR as a prognostic marker in NSCLC.
- While requiring confirmation in larger cohorts, the observed differences in pCR and MPR rates across molecular subgroups suggest a potential role for mutation-informed treatment intensification strategies.
- Progression before surgery and early post-surgical relapse identified high-risk phenotypes. Earlier identification of these patients may help refine treatment strategies.
Post-surgical molecular residual disease and pathological complete response after perioperative nivolumab in resectable stage III NSCLC: exploratory analysis from NADIM II
Key takeaways
- pCR was uniformly associated with post-surgical MRD negativity and excellent 5-year survival.
- Among patients non-pCR, post-surgical MRD status refined prognosis: MRD negativity identified patients with favorable long-term outcomes, whereas detectable MRD defined a high-risk subgroup with early recurrence.
- These findings support integrating pathological response and post-surgical MRD assessment to guide future response-adapted strategies, including postoperative de-escalation and intensification.
Pathological complete response explains part, but not all, of the survival benefit in NADIM II: a causal mediation analysis
Key takeaways
- Pathological complete response is a significant but partial mediator of survival benefit (32% OS, 47% PFS).
- A substantial pathological complete response-independent treatment effect persists, suggesting additional biological mechanisms.
- Pathological complete response is supported as an informative intermediate endpoint, but survival endpoints remain essential.
Efficacy of pumitamig (PD-L1 x VEGF-A bsAb) plus chemotherapy in patients with SCLC and TNBC with brain metastases: subgroup analyses of two phase 2 trials
Key takeaways
- Patients with SCLC or TNBC with brain metastases benefitted from pumitamig + chemotherapy, both systemically and intracranially (confirmed intracranial ORR 32.4% in SCLC and 42.9% in TNBC; systemic cORR was similar with vs without brain metastases, e.g. 1L SCLC 77.8% vs 75.9%, TNBC 57.1% vs 57.4%).
- The safety profile was manageable and generally consistent in patients with or without brain metastases.
- These data support further investigation of pumitamig efficacy in patients with brain metastases.
Izalontamab brengitecan (iza-bren) versus physician's choice chemotherapy in patients with unresectable locally advanced, recurrent or metastatic hormone receptor-positive/HER2-negative breast cancer: A randomized, phase III study
Key takeaways
- In this pre-specified analysis, iza-bren demonstrated a statistically significant and clinically meaningful improvement in PFS vs TPC in previously treated HR+/HER2- BC, meeting the primary endpoint (median PFS by BICR 8.2 vs 4.0 months; HR 0.41, 95% CI 0.33–0.53; p<0.0001).
- Iza-bren demonstrated an improved confirmed ORR and more durable response than TPC (ORR 40.5% vs 20.2%; median DoR 6.9 vs 4.2 months).
- OS is immature at this interim analysis, no detrimental effect was observed.
- The safety profile of iza-bren was manageable and consistent with previous studies. TRAEs leading to discontinuation (1.6%) were low. The incidence of adjudicated ILD was 1.1% (grade ≥3 TRAEs 85.3% vs 65.8%).
Results from a phase 3 trial of neoadjuvant chemotherapy alone vs in combination with nivolumab followed by postsurgical adjuvant nivolumab in patients with muscle-invasive bladder cancer
Key takeaways
- Neither co-primary endpoint met its prespecified threshold. pCR was numerically higher with nivolumab + GC (39.1% vs 29.6%) but not statistically significant after multiplicity adjustment. EFS was not improved (HR 0.94; 95% CI 0.72-1.24).
- OS showed no clear difference (HR 0.88; 95% CI 0.64-1.21). It was analysed descriptively, with median OS not reached in either arm.
- No clear subgroup signal by PD-L1 status, clinical T stage or renal function.
- ctDNA was prognostic in both arms. In exploratory analyses, ctDNA negativity before treatment or clearance during neoadjuvant therapy was associated with better EFS and OS.
- Safety was consistent with the individual agents, with similar TRAE incidence between arms.
Real-world outcomes of adjuvant nivolumab in patients with localized muscle invasive urothelial carcinoma: the ambispective URADJ study
Key takeaways
In this largest French real-world cohort of patients with MIUC and tumor cell PD-L1 ≥1% receiving adjuvant nivolumab, DFS outcomes were consistent with those reported in CheckMate 274 and no new safety signals were identified (6-month DFS 82.1%, 12-month DFS 69.2%; any TRAE 44.4%, grade 3/4 TRAEs 7.9%).
WITNESS: Real-world 3-year outcomes of nivolumab + ipilimumab as first-line treatment in advanced clear cell RCC — final analysis
Key takeaways
- In this prospective nationwide French cohort, first-line nivolumab plus
ipilimumab showed clinically meaningful effectiveness (median Overall Survival: 31.5 months, median Progression-Free Survival: 9.4 months) and a safety profile (24.3% of patients with serious treatment-related adverse events) consistent with the established characteristics of combined PD-1 and CTLA-4 blockade in a heterogeneous routine-care population with advanced renal cell carcinoma (aRCC). - The results support the clinical relevance of the regimen in routine practice and provide evidence from patient groups under-represented in pivotal trials, while highlighting poorer outcomes in patients with adverse baseline prognostic features
Plasma kidney injury molecule-1 dynamics during first-line immunotherapy with or without cabozantinib in advanced renal cell carcinoma
Key takeaways
How a Blood Biomarker Predicts Treatment Benefit in Kidney Cancer:
*Scientific Insight: KIM-1 reflects biologically distinct RCC states.
*Clinical Relevance: Early KIM-1 change may predict benefit from dual IO therapy.
*Development Strategy: Biomarker-driven escalation with TKI in patients with IO-resistant biology.
Potential Impact:
- Biomarker-informed trial design
- Precision treatment
- Increased probability of response
Phase II study of izalontamab brengitecan (iza-bren) combined with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)
Key takeaways
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First results from a phase 2 trial of second-line pumitamig (PD-L1 x VEGFA bsAb) plus chemotherapy in unresectable neuroendocrine neoplasms
Key takeaways
- In this first trial evaluating a PD-(L)1 x VEGF-A bsAb in patients with unresectable NEC, pumitamig plus chemotherapy
showed encouraging antitumor efficacy in the second-line setting, where treatment options are limited
▪ cORR 40.0%
▪ Median PFS 5.5 months
▪ Median OS 12.8 months - Given the modest outcomes reported historically in the second-line setting,1 these findings suggest that pumitamig plus
chemotherapy may represent an encouraging therapeutic approach for patients with unresectable NEC - Pumitamig plus chemotherapy showed a manageable safety and tolerability profile, with a low rate of treatment
discontinuation - Pumitamig is currently being evaluated in four global phase 3 studies in thoracic tumors, one first-line global phase 2/3
study in CRC, and one first-line global phase 2/3 study in gastric cancer*
Safety and efficacy of nivolumab and the nivolumab and ipilimumab combination in advanced HIV associated Kaposi sarcoma (AMC 095)
Key takeaways