The Targeted Pulse: Good News for Advanced CLL/SLL With BGB-16673 Receiving Fast Track Designation and Sonrotoclax Plus Zanubrutinib Showing Promise, and More

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FDA Expedites Development of BGB-16673 For Advanced CLL/SLL

BGB-16673 has received fast-track designation from the FDA for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This orally available Bruton tyrosine kinase (BTK)-targeting chimeric degradation activation compound may be eligible for accelerated approval and priority review if the criteria are met. The FDA designation is based on data from a phase 1/2 study (NCT05006716) that evaluated the dose-escalation and expansion of BGB-16673 in patients with B-cell malignancies, including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, CLL, SLL, Waldenström’s macroglobulinemia, and diffuse large B-cell lymphoma.

“We believe BGB-16673 strengthens our hematology leadership and complements [zanubrutinib (Brukinsa)] the backbone for our investigational hematology pipeline. BGB-16673 is the most advanced BTK degrader in the clinic and is well-suited to become an important therapy for patients progressing after BTK [inhibitors] who have limited options,” Mehrdad Mobasher, MD, MPH, said. Mobasher is chief medical officer of Hematology at BeiGene.

Revealing the Latest Analysis on Lurbinectedin vs Topotecan for ES-SCLC

In this discussion, Ticiana Leal, MD, examines the latest data comparing the benefits of lurbinectedin (Zepzelca) vs topotecan in extensive-stage small cell lung cancer (ES-SCLC) through the case of a 58-year-old man diagnosed with the condition. Key trial data, including the phase 3 ATLANTIS trial (NCT02566993), the basket phase 2 trial (NCT02454972), and the phase 2 DeLLphi-301 trial (NCT05060016), as well as real-world data, are highlighted to explore the comparison between these 2 agents.

“[Data on] lurbinectedin in the monotherapy experience in second line and beyond were published in a retrospective chart review of patients receiving lurbinectedin early on after the approval of lurbinectedin at a single site, showing that lurbinectedin was being used for ES-SCLC in 64 of [90] patients.Fifty patients received it in second line, and 14 patients received it in the third line.The…patients who received it in second or third line…included those with de novo as well as transformed SCLC,” Leal said in the discussion. Leal is director of the Thoracic Medical Oncology Program, associate professor in the Department of Oncology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia.

Sonrotoclax Plus Zanubrutinib Shows Promise in Early CLL/SLL Trial Phases

In the phase 1 BGB-11417-101 study (NCT04277637), sonrotoclax (BGB-11417) in combination with zanubrutinib (Brukinsa) demonstrated improved responses in patients with R/R CLL/SLL. The ongoing BGB-11417-101 study is comparing sonrotoclax alone, or in combination with zanubrutinib and/or obinutuzumab (Gazyva), in patients with R/R CLL/SLL, R/R mantle cell lymphoma, or treatment-naive CLL/SLL. The primary end points of the study are assessing safety and determining the maximum tolerated dose and recommended phase 2 dose.

“We have a lot of experience combining BTK) inhibitors with BCL2 inhibitors… In this study, we are comparing the combination of sonrotoclax and zanubrutinib to the standard of care, venetoclax [Venclexta] and obinutuzumab [Gazyva],” Mazyar Shadman, MD, MPH, Innovators Network Endowed Chair; associate professor, Clinical Research Division, Fred Hutch Cancer Center; associate professor, Medical Oncology Division, University of Washington School of Medicine, told Targeted Oncology^TM in an interview.

How a Tumor Board Is Changing Financial Toxicity in Cancer Care

In an interview with Thomas “Greg” Knight, MD, regarding the initiation of the Levine Cancer Institute Financial Toxicity Tumor Board, Knight provides a step-by-step guide for clinicians who endeavor to address financial challenges faced by patients receiving cancer treatment. Knight is an associate professor in the Department of Internal Medicine, Section on Hematology and Oncology at Wake Forest School of Medicine and chairs the Financial Toxicity Board at Atrium Health Levine Cancer Institute in Charlotte, North Carolina.

“The first thing [I tell people] is to gather your stakeholders. It requires buy-in from people who [usually] don’t talk. That’s one of the model’s biggest advantages, but you have to start talking to these people to ensure your administrative, financial, patient assistance people are all on board while also getting clinician buy-in to ensure they are on board. After the first couple of meetings, people really get excited about the process,” Knight said in the interview.

Unpacking Chemo Choices in HER2+ Breast Cancer: What Do Clinicians Think?

In this Case-Based Roundtable® event, moderated by Ian Krop, MD, PhD, clinicians discuss the choice between paclitaxel and docetaxel as first-line chemotherapy regimens for HER2-positive breast cancer. Five clinicians from various institutions share their perspectives, offering a comprehensive view of the treatment landscape.

“They’re both clearly effective. There are phase 2 studies using paclitaxel, and then there was the original phase 3 study using docetaxel. I think some oncologists, including myself, find that paclitaxel tends to be better tolerated in the metastatic setting, but it does require weekly visits, and docetaxel is typically given every 3 weeks so there is that issue. For some patients, frequency of visits can be an issue, and docetaxel helps that,” Krop said in the discussion. Krop is a professor of internal medicine at Yale School of Medicine, director of the Clinical Trials Office and chief clinical research officer. He is also associate director of Clinical Sciences at the Yale Cancer Center in New Haven, Connecticut.

Thank you for joining us for this week’s Targeted Pulse. Look out for more recaps to come.

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