The OncFive: Top Oncology Articles for the Week of 5/10

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:

FDA Approves T-DXd for Early-Stage HER2+ Breast Cancer

The FDA cleared fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for two early-stage HER2-positive breast cancer indications: neoadjuvant treatment of stage II or III disease (immunohistochemistry [IHC] 3+ or in situ hybridization [ISH]+) followed by taxane, trastuzumab (Herceptin), and pertuzumab (Perjeta; THP), and adjuvant treatment of patients with residual invasive disease after neoadjuvant HER2-targeted therapy.

The neoadjuvant approval was based on data from the phase 3 DESTINY-Breast11 trial (NCT05113251), in which T-DXd followed by THP (n = 321) elicited a pathological complete response rate of 67.3% (95% CI, 61.9%-72.4%) vs 56.3% (95% CI, 50.6%-61.8%) with doxorubicin and cyclophosphamide followed by THP (n = 320; P =.003).

The adjuvant indication was based on findings from the phase 3 DESTINY-Breast05 trial (NCT04622319), in which T-DXd (n = 818) induced a 3-year invasive disease-free survival rate of 92.4% (95% CI, 89.7%-94.4%) vs 83.7% (95% CI, 80.2%-86.7%) with ado-trastuzumab emtansine (Kadcyla; T-DM1; n = 817; HR, 0.47; 95% CI, 0.34-0.66; P <.0001).

The prescribing information includes a boxed warning for interstitial lung disease (ILD) and pneumonitis, as well as warnings for neutropenia and left ventricular dysfunction.

FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma

The FDA has granted accelerated approval to sonrotoclax (Beqalzi) for use in adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least 2 previous lines of systemic therapy, including a BTK inhibitor, supported by data from the phase 1/2 BGB-11417-201 trial (NCT05471843).

In 103 evaluable patients previously treated with an anti-CD20–based therapy and a BTK inhibitor, sonrotoclax elicited an overall response rate of 52% (95% CI, 42%-62%) with a median time to response of 1.9 months and a median duration of response of 15.8 months (95% CI, 7.4-not estimable [NE]) at a median follow-up of 11.9 months.

In the safety-evaluable population (n = 115), any-grade treatment-emergent adverse effects (TEAEs) occurred in 96.5% of patients; grade 3 or higher TEAEs were reported in 52.2% of patients.

The most common TEAEs included neutropenia (any-grade, 35.7%; grade ≥3, 19.1%), thrombocytopenia (24.3%; 9.6%), and anemia (24.3%; 7.8%). The prescribing information includes warnings for tumor lysis syndrome, serious infections, and neutropenia.

FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML

The FDA has cleared the all-oral regimen of decitabine and cedazuridine (Inqovi) plus venetoclax (Venclexta) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are at least 75 years of age or have comorbidities precluding intensive induction chemotherapy. The decision was supported by data from the phase 2 ASCERTAIN-V study (NCT04657081).

In the primary efficacy population, patients achieved a complete response (CR) rate of 41.6% (95% CI, 31.9%-51.8%) with a median time to CR of 2 months (range, 0.4-15.3). Updated data at a median follow-up of 11.2 months showed a CR rate of 46.5% (95% CI, 36.5%-56.7%), a CR/CR with incomplete hematologic recovery rate of 63.4% (95% CI, 53.2%-72.7%), and a median overall survival (OS) of 15.5 months (95% CI, 7.6-NE).

Grade 3 or higher treatment-related adverse effects (TRAEs) occurred in 72.3% of patients (n = 101), with the most common being neutropenia (25.7%), febrile neutropenia (24.8%), decreased platelet count (24.8%), and anemia (29.7%); AEs led to fatal outcomes in 15.8% of patients.

FDA Approves Adjuvant Atezolizumab for MRD+ Muscle-Invasive Bladder Cancer

The FDA gave the green light to atezolizumab (Tecentriq) and subcutaneous atezolizumab/hyaluronidase-tqjs (Tecentriq Hybreza) as adjuvant treatment in adult patients with muscle-invasive bladder cancer (MIBC) following cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD), as determined by the concurrently approved Signatera CDx companion diagnostic.

Approval was supported by the phase 3 IMvigor011 trial (NCT04660344), in which adjuvant atezolizumab led to a median disease-free survival (DFS) of 9.9 months (95% CI, 7.2-12.7) vs 4.8 months (95% CI, 4.1-8.3) with placebo (HR, 0.64; 95% CI, 0.47-0.87; P =.0047). Atezolizumab also led to a median OS benefit of 32.8 months (95% CI, 27.7-NE) vs 21.1 months (95% CI, 14.7-NE) with placebo (HR, 0.59; 95% CI, 0.39-0.90; P =.0131).

Grade 3/4 adverse effects (AEs) occurred in 28.5% of atezolizumab-treated patients (n = 165) vs 21.7% with placebo (n = 83), with immune-mediated AEs in 38.8% vs 12.0%, respectively; TRAEs led to death in 1.8% vs 0%.

FDA Issues Warning Regarding Risk of Secondary Primary Malignancies With Tazemetostat in Follicular Lymphoma, Epithelioid Sarcoma

The FDA has issued a safety alert after Ipsen’s voluntary withdrawal of tazemetostat (Tazverik) from all approved indications in the United States—including relapsed/refractory follicular lymphoma and metastatic or locally advanced epithelioid sarcoma—because of an increased rate of hematologic secondary primary malignancies (SPMs).

Findings from the phase 3 SYMPHONY-1 trial (NCT04224493), examining tazemetostat in combination with lenalidomide (Revlimid) and rituximab (Rituxan; R2) in relapsed/refractory follicular lymphoma, revealed an SPM rate of 5.7% at a median treatment duration of 15.8 months (range, 6.9-33) in patients receiving the combination (n = 318) vs no SPMs in the placebo/R2 control arm. Most SPMs were myelodysplastic syndrome and acute myeloid leukemia (AML), with 3 deaths and 14 unresolved cases among the 18 affected patients as of March 6, 2026; SPMs were reported as early as 7.5 months after treatment initiation and also occurred after treatment completion.

Ipsen has halted tazemetostat treatment in SYMPHONY-1, transitioning all patients to R2 alone, although the study remains open for long-term safety follow-up.