The OncFive: Top Oncology Articles for the Week of 11/17

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:

FDA Approves Zanidatamab for Previously Treated, Unresectable or Metastatic HER2+ Biliary Tract Cancer

The regulatory agency awarded accelerated approval to zanidatamab-hrii (Ziihera) for use in adult patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test based on findings from the phase 2b HERIZON-BTC-01 trial (NCT04466891). The agent (n = 62) elicited an overall response rate of 52% (95% CI, 39%-65%) with an estimated response duration of 14.9 months (95% CI, 7.4-not estimable). This is the first and only dual HER2-targeted bispecific antibody and chemotherapy-free treatment for this population.

Nogapendekin Alfa Inbakicept Plus BCG Maintains CR Rate in BCG-Unresponsive NMIBC With CIS

Updated findings from the phase 2/3 QUILT-3.032 study (NCT03022825) showed that nogapendekin alfa inbakicept-pmln (N-803; Anktiva) paired with Bacillus Calmette–Guérin (BCG) continued to generate complete responses (CR) in patients with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ. “We are encouraged by the consistent CR rates observed in our expanded patient cohort,” Patrick Soon-Shiong, MD, executive chairman and global chief scientific and medical officer of ImmunityBio, stated in a news release.

CDK4/6 Inhibitors, Targeted Therapies May Expand Their Reach in HR+ Metastatic Breast Cancer

In an interview with OncLive, Hope S. Rugo, MD, of the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, discussed unresolved questions regarding the efficacy of adjuvant CDK4/6 inhibitors in patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. She also discussed potential options for those who progress on CDK4/6 inhibitors; the role of targeted therapies and how they could expand for this population; and how her current approach to treatment sequencing may evolve based on the presence or absence of actionable mutations and the emergence of new data. “Over time, there are going to be expanded treatment options with drugs that target the PI3K pathway, as well as new endocrine therapies,” she said.

Versamune HPV Could Bolster Long-Term Efficacy With Pembrolizumab in HPV16-Driven HNSCC

The global, active comparator-controlled, randomized VERSATILE-003 study is evaluating the safety and efficacy of the investigational immunotherapy Versamune HPV (formerly PDS0101) plus pembrolizumab (Keytruda) vs single-agent pembrolizumab in immune checkpoint inhibitor–naive patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma. This clinical trial spotlight article includes insights from Kevin Harrington, BSc, MBBS, PhD, MRCP, FRCP, FRCR, of The Royal Marsden NHS Foundation; Katharine Price, MD, of Mayo Clinic Comprehensive Cancer Center; and Jared Weiss, MD, of the University of North Carolina School of Medicine in Chapel Hill.

Bendamustine/Obinutuzumab Induction Generates Responses and MRD Negativity in Treatment-Naive MCL

Data from the phase 2 study (NCT03311126) published in Clinical Lymphoma, Myeloma & Leukemia showed that induction bendamustine paired with obinutuzumab (Gazyva) proved tolerable and elicited a higher complete response rate than historical data for bendamustine plus rituximab (Rituxan) in patients with treatment-naive mantle cell lymphoma. Moreover, the median progression-free survival was 46.5 months (95% CI, 35.1-not applicable) at a median follow-up of 43.9 months (95% CI, 28.3-60.1). The PFS rates were 66.0% (95% CI, 41.6%-82.2%) and 58.7% (95% CI, 33.2%-77.3%) at 2 and 3 years, respectively. Data also indicated that the omission of maintenance obinutuzumab in those who achieved minimal residual disease negativity did not lead to worse outcomes than those who did.