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Inavolisib triplet wins FDA approval in PIK3CA+ breast cancer, perioperative pembrolizumab improves EFS in head and neck cancer, and more from OncLive this week.
Welcome to OncLive®’s OncFive! Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types.
Here’s what you may have missed this week:
On October 10, 2024, the regulatory agency approved inavolisib (Itovebi) plus palbociclib (Ibrance) and fulvestrant (Faslodex) for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer after recurrence on or following the completion of adjuvant endocrine therapy. The decision was based on findings from the phase 3 INAVO120 study (NCT04191499) in which the inavolisib triplet improved progression-free survival over palbociclib/fulvestrant, at a median of 15.0 months (95% CI, 11.3-20.5) and 7.3 months (95% CI, 5.6-9.3), respectively (HR, 0.43; 95% CI, 0.32-0.59; P < .0001).
Perioperative Pembrolizumab Meets EFS End Point in Newly Diagnosed, Resected Stage III/IVA HNSCC
Data from the phase 3 KEYNOTE-689 trial (NCT03765918) showed that neoadjuvant pembrolizumab (Keytruda), followed by pembrolizumab plus radiotherapy with or without cisplatin, and maintenance pembrolizumab, resulted in a significant improvement in event-free survival over adjuvant radiotherapy with or without cisplatin in patients with newly diagnosed, resected stage III or IVA, locally advanced head and neck squamous cell carcinoma. A significant improvement in major pathological response was also observed in the pembrolizumab arm, as well as a trend toward improvement in overall survival (OS).
2023 Chemotherapy Shortages Drove Altered Treatment Plans, Persistent Cost Increases
Data from an analysis shared during the 2024 ASCO Quality Care Symposium showed that the 2023 cisplatin shortage in the United States led to a shift toward the use of alternative chemotherapy drugs for use in patients with head and neck cancer, as well as increased overall and per-administration costs of such drugs. During the drug shortage period, the use of cisplatin at the oncology centers included in the study dropped by 15%; these centers increased their use of carboplatin, paclitaxel, cetuximab (Erbitux), and fluorouracil by 40%, 24%, 15%, and 5%, respectively.
ADC and CDK4/6 Inhibitor Decision-Making and Sequencing Questions Abound in Breast Cancer
In an exclusive interview with OncLive, Yuan Yuan, MD, PhD, discussed emerging therapeutic options for patients with hormone receptor–positive breast cancer who have progressed on CDK4/6 inhibition, the importance of individualized radiation therapy approaches, and where HER2-directed antibody-drug conjugates may fit into the treatment paradigm to reflect recent expansions of the definition of HER2 expression. Yuan is a professor of medicine, director of Breast Oncology, and the medical director of the Breast Oncology Disease Research Group at Cedars-Sinai Medical Center in Los Angeles, California, and a health sciences clinical professor at the University of California, Los Angeles.
Talazoparib Plus Enzalutamide Improves OS in mCRPC
Updated data from the phase 3 TALAPRO-2 study (NCT03395197) showed that talazoparib (Talzenna) paired with enzalutamide (Xtandi) improved OS vs single-agent enzalutamide in patients with metastatic castration-resistant prostate cancer. The survival improvement was observed in all-comers enrolled in cohort 1 and in those with homologous recombination repair gene mutations enrolled in cohort 2. Full data from the study are planned to be shared at an upcoming medical meeting and with global health authorities to support label expansion of the regimen.