A Collection of Hematology & Oncology Articles
The practice of oncology and hematology is in constant evolution. These articles highlight some of the most notable advancements and discoveries in the modern medical world. We invite you to use this site frequently and collaborate with medical professionals across the globe.
Welcome
At Florida Cancer Specialists & Research Institute (FCS), our physicians and advanced practice providers are deeply vested in clinical research to provide the most cutting-edge treatment options available to our patients. In our own practices we are fortunate to offer over 300 clinical trials across 37 locations including 3 dedicated Phase 1 Drug Development Units. We value every opportunity to share best practices and the latest research both within and outside of our institution. We welcome you to use this collection as a resource to support your own research and understanding as we strive together to advance cancer care one step at a time.
Recent Articles
Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
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.
Isatuximab for relapsed and/or refractory AL amyloidosis: results of a prospective phase 2 trial (SWOG S1702)
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.
Simultaneous Durvalumab and Platinum-Based Chemoradiotherapy in Unresectable Stage III Non–Small Cell Lung Cancer: The Phase III PACIFIC-2 Study
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.
RP1 Combined With Nivolumab in Advanced Anti–PD-1–Failed Melanoma (IGNYTE)
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.
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
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.
Ziftomenib in Relapsed or Refractory NPM1-Mutated AML
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.
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
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.
Sevabertinib in Advanced HER2-Mutant Non–Small-Cell Lung Cancer
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.
FCS Physician Focus
Plasma Proteome–Based Test for First-Line Treatment Selection in Metastatic Non–Small Cell Lung Cancer
FCS medical oncologist and hematologist Ernesto Bustinza-Linares, MD has co-authored an abstract published in the American Society of Clinical Oncology Journal, JCO Precision Oncology, that uncovers a new testing method to determine personalized care options for patients with metastatic non-small cell lung cancer (NSCLC). The abstract’s authors address the limitations of existing guidelines that recommend checkpoint immunotherapy, sometimes in combination with chemotherapy, for treating NSCLC, which often discounts patient variability and immune factors. The findings from the study show that by incorporating additional plasma proteome-based testing, combined with the standard protein inhibitor testing, clear differences in patient outcomes were observed after applying targeted treatments based on the testing results.
Florida Cancer Specialists & Research Institute