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The OncFive: Top Oncology Articles for the Week of 6/15

Tafasitamab combination gets approval in follicular lymphoma, FDA declines to expand label for talazoparib plus enzalutamide in mCRPC, and more.

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

Top Oncology Article of the Week: #1

Top Oncology Article of the Week: #1

FDA Approves Tafasitamab Plus Lenalidomide and Rituximab for R/R Follicular Lymphoma

The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for adult patients with relapsed or refractory follicular lymphoma, marking the first CD19- and CD20-directed immunotherapy regimen for this population. The approval is based on phase 3 inMIND trial (NCT04680052) data, where the triplet regimen significantly improved progression-free survival (PFS) compared with lenalidomide and rituximab alone, at 22.4 months vs 13.9 months per investigator assessment (HR, 0.43; P < .0001). Independent review further supported the benefit, showing median PFS was not yet reached in the tafasitamab arm. Safety findings were consistent with immunotherapy use, with serious adverse effects reported in 33% of patients and serious infections experienced by 24% of patients. The most common grade 3/4 lab abnormalities included neutropenia and lymphopenia. This approval provides a chemotherapy-free option for patients with relapsed follicular lymphoma and may represent a new treatment standard for this often-recurrent disease.

Top Oncology Article of the Week: #2

Top Oncology Article of the Week: #2

Hematologists Highlight Notable Insights From the 2025 EHA Congress

The 2025 EHA Congress highlighted major advances across hematologic malignancies, with experts spotlighting new mechanisms, novel agents, and practice-shaping clinical data. In chronic lymphocytic leukemia, BTK degraders emerged as a promising strategy for heavily pretreated patients, including those who have progressed after covalent and noncovalent BTK inhibitors. In acute myeloid leukemia, updated results from menin inhibitor studies and combinations like oral decitabine plus venetoclax (Venclexta) pointed toward new therapeutic directions for both newly diagnosed and relapsed/refractory populations. In multiple myeloma, the MIDAS trial (NCT04934475) showed potent minimal residual disease (MRD)–negativity rates with isatuximab-irfc (Sarclisa) plus carfilzomib (Kyprolis), lenalidomide, and dexamethasone induction and questioned the need for tandem transplant in MRD-positive patients. Sign up to access this exclusive recap, which features insights from at least 6 key opinion leaders.

Top Oncology Article of the Week: #3

Top Oncology Article of the Week: #3

FDA Declines to Expand Label for Talazoparib/Enzalutamide in mCRPC

The FDA has declined to broaden the label for talazoparib (Talzenna) plus enzalutamide (Xtandi) to include patients with non–homologous recombination repair (HRR)–mutated metastatic castration-resistant prostate cancer (mCRPC), following a unanimous Oncologic Drugs Advisory Committee vote against the expansion. However, the agency did update the combination’s existing indication with final overall survival (OS) data from the phase 3 TALAPRO-2 trial (NCT03395197), reinforcing its role in patients with HRR gene mutations. In the broader unselected population, the regimen showed a statistically significant OS improvement, but the benefit was primarily driven by the HRR-positive subgroup. Despite meaningful gains in radiographic progression-free survival and OS for the overall cohort, the regulatory agency concluded that the benefit-risk profile was insufficient in HRR-negative disease. This decision underscores the continued importance of biomarker-driven strategies in mCRPC treatment selection.

Top Oncology Article of the Week: #4

Top Oncology Article of the Week: #4

Post Hoc Analysis Shows Imetelstat Drives Benefit in RS-Negative, Lower-Risk MDS

Imetelstat (Rytelo) demonstrated meaningful clinical activity in patients with ring sideroblast (RS)–negative, lower-risk myelodysplastic syndrome (MDS) who were relapsed/refractory to or ineligible for erythropoiesis-stimulating agents (ESAs), according to findings from a post hoc analysis of the phase 2/3 IMerge trial (NCT02598661) presented at the 2025 EHA Congress. Among 78 RS-negative patients treated with imetelstat, 33% achieved red blood cell transfusion independence (RBC-TI) for at least 8 weeks, and 13% sustained TI for at least 1 year, with many also experiencing hemoglobin increases and erythroid improvement. The benefit was seen across both low and high transfusion burden subgroups and was accompanied by improvements in patient-reported fatigue. The median duration of RBC-TI in long-term responders exceeded 2 years, highlighting the durability of benefit. These data further support imetelstat’s role as a non-ESA option in RS-negative MDS, a group that has historically faced limited treatment options.

Top Oncology Article of the Week: #5

Top Oncology Article of the Week: #5

VERONA Trial Misses Primary End Point of OS Benefit With Azacitidine/Venetoclax in Higher-Risk MDS

The phase 3 VERONA trial (NCT04401748) evaluating venetoclax plus azacitidine (Vidaza) in patients with newly diagnosed higher-risk MDS did not meet its primary end point of OS. The combination did not significantly improve OS vs placebo plus azacitidine (HR, 0.908; P = .3772), although no new safety signals were observed. These findings follow earlier data from a phase 1b trial (NCT02942290), which showed promising response rates and a median OS of 26 months with the regimen. VERONA was designed to confirm those benefits in a larger population but ultimately fell short. This outcome does not affect any of venetoclax’s currently approved indications.


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