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Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma

November 1, 2025

The EPCORE NHL-2 phase 1b/2 trial evaluated fixed-duration epcoritamab plus R2 in R/R FL after at least one prior line, showing impressive efficacy with an overall response rate (ORR) of 96% and a complete response (CR) of 88%, and 2-year rates for remaining in CR (82%), progression-free survival (PFS) (76%), overall survival (OS) (90%), and freedom from next therapy (84%)—all with non-reached medians. High-risk groups did just as well, with CR rates of 90% in primary refractory, 82% in double refractory. MRD negativity was achieved by 86% overall. Safety was manageable, with mostly low-grade CRS (grade 1/2/3: 38%/11%/2%), neutropenia (65%), and COVID-19 (59%)—notably, no CRS-related discontinuations. This chemo-free, off-the-shelf regimen is delivering deep, durable remissions with practical outpatient dosing—something we’ve all been hoping to see for R/R FL.

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Isatuximab for relapsed and/or refractory AL amyloidosis: results of a prospective phase 2 trial (SWOG S1702)

November 1, 2025

SWOG S1702 was a multicenter phase II trial of isatuximab monotherapy in rrAL, showing an impressive overall response rate (ORR) of 77% with ≥VGPR in 57% and rapid responses (median time to PR or better 1.1 months). Organ responses were meaningful—renal 50% and cardiac 57%—with encouraging 24-month PFS (74%) and overall survival (OS) (85%). The safety profile was favorable, with grade ≥3 TRAEs in 23% (notably lymphopenia 8.5% and infections 6%), and most infusion-related reactions (IRRs) were low-grade and limited to cycle 1. Prior daratumumab therapy was allowed but the patient needed to be deemed still sensitive to CD38-Ab therapy. Bottom line: Single-agent anti-CD38 with isa delivers fast, deep hematologic and organ responses in rrAL with manageable toxicity—a low-tox option to consider early at relapse.

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Simultaneous Durvalumab and Platinum-Based Chemoradiotherapy in Unresectable Stage III Non–Small Cell Lung Cancer: The Phase III PACIFIC-2 Study

November 1, 2025

PACIFIC-2 was a phase III trial testing durva given concurrently with cCRT (and continued as consolidation) versus placebo + cCRT in unresectable stage III NSCLC, and it did not meet its primary endpoint. The overall response rate (ORR) was essentially identical (60.7% vs 60.6%), and pneumonitis rates were similar (any grade 28.8% vs 28.7%; grade ≥3: 4.6% vs 5.6%), but adverse events (AEs) leading to discontinuation and fatal AEs were higher with durva (25.6% vs 12.0%; 13.7% vs 10.2%), especially early on. Starting IO up front with cCRT didn’t improve outcomes and added early toxicity—consolidation durva after cCRT is still the way to go.

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RP1 Combined With Nivolumab in Advanced Anti–PD-1–Failed Melanoma (IGNYTE)

November 1, 2025

The IGNYTE phase II trial evaluated RP1 (an HSV-1-based oncolytic immunotherapy) plus nivo in anti-PD-1-failed melanoma, showing an overall response rate (ORR) of 32.9% with 15.0% complete response (CRs) and deep, systemic responses in both injected and noninjected lesions. Median duration of response (DOR) was 33.7 months (14.1 to NR), progression-free survival (PFS) was modest overall at 3.6 months (2.0-5.0) but much longer in responders (35.5 months vs 1.9 months in nonresponders), and overall survival (OS) rates were encouraging at 1 and 2 years (75.3% and 63.3%, median OS NR). Safety was favorable, with mostly grade 1/2 TRAEs (77.1%) and low grade 3/4 rates (9.3%/3.6%), and biomarker data showed on-treatment immune activation. For our anti-PD-1-refractory melanoma patients, RP1+nivo looks like a practical, immunotherapy-only option with real durability in responders and manageable toxicity. This is definitely one to watch as we await randomized data.

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Development and Validation of an Artificial Intelligence Digital Pathology Biomarker to Predict Benefit of Long-Term Hormonal Therapy and Radiotherapy in Men With High-Risk Prostate Cancer Across Multiple Phase III Trials

November 1, 2025

A new MMAI-derived digital pathology biomarker was trained and prospectively validated across multiple NRG/RTOG phase III trials, including RTOG 9202 (N=1,192), to predict which high-risk/locally advanced PCa patients benefit from LT-ADT vs ST-ADT with RT. In the overall cohort, LT-ADT reduced DM (17% vs 26% at 15 years) and DDM (15% vs 23% at 15 years), but this benefit was limited to biomarker-positive patients (DM: 19% vs 33%; DDM: 19% vs 30%), with no advantage seen in biomarker-negative patients (DM: 11% vs 11%; DDM: 9% vs 10%). This tool could allow about a third of our "high-risk" patients to avoid two extra years of ADT without compromising metastasis outcomes, while ensuring we intensify for those most likely to benefit. In short, this is a practical step toward personalizing ADT duration and sparing toxicity for a significant subset of our patients.

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Ziftomenib in Relapsed or Refractory NPM1-Mutated AML

November 1, 2025

Ziftomenib 600 mg daily achieved a CR/CRh rate of 22% (61% MRD-negative among responders) and an overall response rate (ORR) of 33% in heavily pretreated R/R NPM1-mutated AML, with a median duration of response (DOR) of 4.6 months and median overall survival (OS) of 6.6 months (18.4 months in responders). Efficacy was consistent across subgroups, including prior venetoclax and FLT3/IDH co-mutations, and safety was manageable with on-target differentiation syndrome in 25% (15% grade 3; no grade 4–5), low myelosuppression, rare QTc prolongation (3%), and only 3% discontinuations for drug-related AEs. This non-cytotoxic, oral menin inhibitor offers meaningful activity in a high-risk population and is a practical option while we await combination data.

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Modified Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin or S-1, Irinotecan, and Oxaliplatin Versus Nab-Paclitaxel + Gemcitabine in Metastatic or Recurrent Pancreatic Cancer (GENERATE, JCOG1611): A Randomized, Open-Label, Phase II/III Trial

November 1, 2025

The GENERATE/JCOG1611 trial in Japanese patients with metastatic or recurrent PDAC found that neither mFOLFIRINOX nor S-IROX improved overall survival (OS) versus nab-paclitaxel/gemcitabine (median OS 14.0 vs 13.6 vs 17.0 months; hazard ratio (HR) ≈1.29), and the study was stopped early for futility. Progression-free survival (PFS) was similar across arms (≈5.8–6.7 months) but nab-paclitaxel/gemcitabine had fewer grade 3–4 GI toxicities and less febrile neutropenia, supporting its continued use in this population. The OS difference likely reflects more effective second-line sequencing after nab-paclitaxel/gemcitabine, including liposomal irinotecan, rather than intrinsic superiority. In Western studies, NALIRIFOX outperformed Nab-P/Gem, but in the Japanese trial, Nab-P/Gem remained at least as effective as triplet regimens, likely due to differences in patient population, sequencing, and access to second-line therapies.

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Sevabertinib in Advanced HER2-Mutant Non–Small-Cell Lung Cancer

November 1, 2025

Sevabertinib shows strong efficacy in HER2-mutant NSCLC, with an overall response rate (ORR) of 64% and median progression-free survival (PFS) of 8.3 months in previously treated, HER2-TKI–naive patients, and an overall response rate (ORR) of 71% with a duration of response (DOR) of 11.0 months in first-line therapy. Activity is highest in TKD mutations, especially Y772_A775dupYVMA, and intracranial responses are seen. Safety is manageable: diarrhea is common but mostly low grade, with grade ≥3 in 5–23% and rare discontinuations. Notably, interstitial lung disease (ILD) was not observed. These data position sevabertinib as a viable oral TKI alongside ADCs for HER2-mutant NSCLC, particularly for TKD/YVMA disease.

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Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer

November 1, 2025

ASCENT-03 shows that in first-line, PD-1/PD-L1–ineligible advanced TNBC, sacituzumab improves PFS to 9.7 vs 6.9 months and extends median duration of response (DOR) to 12.2 vs 7.2 months, with similar overall response rate (ORR) (48% vs 46%) and immature overall survival (OS) (21.5 vs 20.2 months) Grade ≥3. Adverse events (AEs) were comparable (66% vs 62%), but sacituzumab had more neutropenia and diarrhea, fewer discontinuations (4% vs 12%), and early-cycle infection-related deaths in patients without primary G-CSF. For PD-1/PD-L1–ineligible mTNBC, SG offers more durable control than chemo with manageable myelosuppression — so consider SG first-line and start G-CSF early in higher-risk patients.

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Engasertib versus Placebo for Bleeding in Hereditary Hemorrhagic Telangiectasia

November 1, 2025

This randomized, double-blind, placebo-controlled phase 1b trial of engasertib (an oral AKT1/2 inhibitor) in patients with HHT with moderate-to-severe epistaxis, showing dose-dependent reductions in epistaxis duration and frequency over 12 weeks, with further improvement through 12 months in the open-label extension. The 40 mg dose reduced monthly epistaxis duration by 41.4% and frequency by 27.8% vs placebo, and increased epistaxis-free days by 4.6/month. Safety was manageable and most notably, no thromboembolic signals were observed. Larger studies are needed, but this could be a game changer for our HHT patients sent to us for management of bleeding and anemia.

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