The OncFive: Top Oncology Articles for the Week of 6/21

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 Sacituzumab Govitecan Monotherapy and In Combination With Pembrolizumab in Frontline TNBC

The FDA has approved sacituzumab govitecan-hziy (Trodelvy) for 2 indications in adults with triple-negative breast cancer (TNBC): monotherapy for frontline use in patients with unresectable locally advanced or metastatic TNBC ineligible for PD-(L)1 inhibitor–based therapy, and in combination with pembrolizumab (Keytruda) or pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex) for those whose tumors express PD-L1, defined as a combined positive score (CPS) of 10 or higher. The monotherapy indication was supported by results from the phase 3 ASCENT-03 trial (NCT05382299), in which sacituzumab govitecan led to a median progression-free survival (PFS) of 9.7 months (95% CI, 8.1-11.1) vs 6.9 months (95% CI, 5.6-8.2) with chemotherapy (HR, 0.62; 95% CI, 0.50-0.77; P<.0001). The combination indication was supported by findings from the phase 3 ASCENT-04/KEYNOTE-D19 trial (NCT05382286), in which sacituzumab govitecan plus pembrolizumab resulted in a median PFS of 11.2 months (95% CI, 9.3-16.7) vs 7.8 months (95% CI, 7.3-9.3) with chemotherapy plus pembrolizumab (HR, 0.65; 95% CI, 0.51-0.84; P =.0009). Grade 3 or higher treatment-emergent adverse effects (TEAEs) occurred in 66% of sacituzumab govitecan–treated patients in ASCENT-03 (n = 275) vs 62% with chemotherapy, and in 71% of patients in both arms of ASCENT-04; the prescribing information carries a boxed warning for diarrhea and neutropenia.

FDA Approves Palbociclib Plus Trastuzumab, With/Without Pertuzumab, and ET as Maintenance in HR+, HER2+ Metastatic Breast Cancer

The FDA has cleared palbociclib (Ibrance) in combination with trastuzumab (Herceptin), plus or minus pertuzumab (Perjeta), and endocrine therapy for maintenance treatment of adult patients with hormone receptor–positive, HER2-positive locally advanced or metastatic breast cancer following induction therapy, supported by results from the phase 3 PATINA trial (NCT02947685). The combination provided a significant investigator-assessed PFS benefit vs trastuzumab, with or without pertuzumab, and endocrine therapy alone (HR, 0.76; 95% CI, 0.59-0.97; 1-sided P =.0134); median PFS values could not be adequately estimated due to censoring. Earlier published data showed 24- and 48-month PFS rates of 65.2% and 46.5% with the palbociclib regimen (n = 261) vs 55.3% and 38.3% with control (n = 257), along with confirmed objective response rates (ORRs) of 32.9% (95% CI, 26.9%-39.4%) vs 24.8% (95% CI, 19.3%-30.0%), respectively. Any-grade adverse effects (AEs) occurred in 100% of palbociclib-treated patients (n = 261) vs 94.4% of those treated with control (n = 248); neutropenia (77.8%), diarrhea (70.5%), and fatigue (53.6%) were most common in the investigational arm.

FDA Grants Full Approval to Afami-Cel for Advanced Synovial Sarcoma

The FDA has granted full approval to afamitresgene autoleucel (afami-cel; Tecelra), a T-cell receptor T-cell therapy, for the treatment of adult and pediatric patients aged 12 years and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for select HLA-A*02 alleles, and whose tumor expresses the MAGE-A4 antigen as determined by an FDA-approved or -cleared companion diagnostic. This decision expands on the August 2024 accelerated approval, which was limited to adults. Full approval was supported by data from cohorts 1, 2, and 3 of the SPEARHEAD-1 trial (NCT04044768), in which afami-cel elicited an ORR of 43.8%, including a complete response rate of 3.6%, with a median duration of response (DOR) of 5.3 months (95% CI, 4.5-8.2); 31.9% of responders achieved a DOR of at least 24 months. The most common AEs of any grade that were experienced by at least 20% of patients included cytokine release syndrome (CRS), nausea, vomiting, fatigue, and infections, with CRS and pleural effusion being the most common serious AEs occurring in at least 5% of patients.

FDA Approves Prefilled Pen for Ropeginterferon Alfa-2b in Polycythemia Vera

The FDA has approved a prefilled pen device for administering ropeginterferon alfa-2b-njft (Besremi), a long-acting, mono-pegylated proline interferon, in adult patients with polycythemia vera (PV), offering a more convenient self-administration alternative to the existing prefilled syringe without altering the approved indication or dosing. Ropeginterferon alfa-2b was originally approved in November 2021 based on safety findings from the phase 1/2 PEGINVERA study (NCT01193699) and the phase 3 PROUD-PV (NCT01949805) and CONTINUATION-PV (NCT02218047) trials, with efficacy data showing that 61% of patients achieved a complete hematological response after 7.5 years of treatment. In PROUD-PV, 21% of ropeginterferon alfa-2b–treated patients achieved the composite primary end point of complete hematological response with normal spleen size at 12 months vs 28% with hydroxyurea; improved disease burden at 36 months in the extension study CONTI-PV favored ropeginterferon alfa-2b (53% vs 38%; P =.044). The most common toxicities in the pooled safety population included influenza-like illness, arthralgia, fatigue, and pruritus, with a boxed warning noting that interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders.

FDA Accepts Third RP1 BLA Resubmission With Nivolumab in Advanced Melanoma

The FDA has accepted for review the resubmitted biologics license application seeking accelerated approval of vusolimogene oderparepvec (RP1) plus nivolumab (Opdivo) for patients with advanced melanoma. A goal date for the decision has been assigned to August 2, 2026, and an advisory committee meeting has been scheduled for late July; this follows 2 prior complete response letters (CRLs). The application is supported by results from the phase 1/2 IGNYTE trial (NCT03767348), which demonstrated a blinded independent central review–assessed ORR of 33.6% (95% CI, 25.8%-42.0%) by modified RECIST in 140 patients with documented progression on prior anti–PD-1 therapy, with a median DOR of 33.7 months (95% CI, 14.1–not reached). Updated 3-year overall survival (OS) data presented at the ASCO Annual Meeting showed that 47.8% of all treated patients remained alive at 3 years; this percentage rose to 83.5% among responders, with 44.8% of responders remaining in response at 3 years. Any-grade and grade 3/4 TRAEs occurred in 90.0% and 12.9% of patients, respectively, with no treatment-related deaths reported and no new long-term safety signals identified.