The Targeted Pulse: Discover Upcoming Meetings, FDA Action, and Key Insights in SCLC and mCSPC

Upcoming Meeting To Discuss Adjuvant/Neoadjuvant Advances in Lung Cancer

The 22nd Annual Winter Lung Cancer Conference® will explore developments in early-stage, locally advanced, and metastatic lung cancer, highlighting key advances in neoadjuvant/adjuvant immunotherapy combined with chemotherapy for patients with early-stage non–small cell lung cancer (NSCLC). The conference, scheduled for January 31 to February 2, 2025, in Hollywood, Florida, is cochaired by Julie R. Brahmer, MD, MSc; Rogerio C. Lilenbaum, MD; and Mark A. Socinski, MD.

“This is a truly multidisciplinary conference that will bring together thoracic surgeons, radiation oncologists, and medical oncologists who treat patients across lung cancer settings,” Brahmer said in an interview with Targeted Therapies in Oncology regarding the upcoming conference. “I think the most important advances we have seen recently are in early-stage NSCLC, with the advent of neoadjuvant immunotherapy plus chemotherapy.”

Brahmer is codirector, Upper Aerodigestive Department, Bloomberg~Kimmel Institute for Cancer Immunotherapy and director, Thoracic Oncology, at Johns Hopkins Medicine in Baltimore, Maryland.

The FDA Moves Obe-cel Forward For Relapsed/Refractory B-ALL

Obecabtagene autoleucel (obe-cel; Aucatzyl), a chimeric antigen receptor (CAR) T-cell therapy, has been approved by the FDA for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). This approval is based on data from the phase 1b/2 FELIX trial (NCT04404660), which were presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition.

In the study, the primary end point was overall remission rate as assessed by independent review and secondary end points were duration of remission, measurable residual disease -negative remission rate, safety, and CAR T expansion and persistence. Patients underwent lymphodepletion with fludarabine (4 doses of 30 mg/m²) and cyclophosphamide (2 doses of 500 mg/m²). Obe-cel was given as a split dose, targeting 410 x 10⁶ CAR T cells, on days 1 and 10, based on the bone marrow blast burden measured before lymphodepletion.

Transformative Therapies For Extensive-Stage SCLC

This year has brought exciting developments in the management of small cell lung cancer (SCLC), leading to transformative therapies and promising trial results. Ariel Lopez-Chavez, MD, discussed these advancements with Targeted Oncology^TM, highlighting the phase 2 DeLLphi-301 study (NCT05060016), the ADRIATIC (NCT03703297) study, and the IMforte (NCT05091567) study. He also addresses the next steps and emerging challenges that will drive these advancements forward.

“For years, the only things we had were topotecan and irinotecan, but as of May of 2020, we got the approval of lurbinectedin. Then more recently, we got the approval of tarlatamab in the second-line setting. Now, we have 4 agents. The use of these agents has been shifting to the newer agents, lurbinectedin and tarlatamab, because they have a better toxicity profile. It is very exciting to have more agents in this space now. The question [now] will be what to choose, in particular, between lurbinectedin and tarlatamab,” said Lopez-Chavez, medical oncologist, director of precision medicine and developmental therapeutics at Allegheny Health Network Cancer Institute, discussed recent developments in the SCLC space.

Evaluating How Apalutamide Improves Survival Vs Enzalutamide in mCSPC

According to real-world data, treatment with apalutamide (Erleada) improved survival compared with enzalutamide (Xtandi) at 24 months. Neal Shore, MD, FACS, offers an in-depth analysis of these real-world data, answering key questions and exploring next steps. Shore is United States chief medical officer of surgery and oncology at GenesisCare USA, and director of the Carolina Urologic Research Center in South Carolina.

“This was a retrospective, longitudinal cohort of patients, largely coming from the Flatiron registry, which is an electronic dataset and patient charts interrogated from January 1, 2013, through May 31, 2023,” Shore explained in the interview with Targeted Oncology^TM “When we looked at important data metrics such as the date of death, their Social Security death index, and other confirmed sources, we took an analysis called an intention-to-treat approach. A Kaplan-Meier analysis used to describe the proportion of patients surviving 2 years, 24 months, postindex.”

LBL-034 Gains FDA Ground in Multiple Myeloma

The FDA has granted orphan drug designation to LBL-034, a humanized, bispecific T-cell-engaging antibody targeting GPRC5D and CD3 for the treatment of multiple myeloma. Investigators are evaluating the agent in a phase 1/2 trial (NCT06049290). Phase 1 will assess dose escalation and dose expansion, and phase 2 will evaluate efficacy. LBL-034 is the third GPRC5D-targeted CD3 T-cell engager in development, with increased potency, reduced risk of T-cell exhaustion, and lower cell death compared to others in its class.

“It is urgent to develop new and more effective treatment options. LBL-034 adopts a unique molecular design, and the preliminary clinical results indicate its promising antitumor efficacy and safety. We will expedite the clinical development of LBL-034 and strive to bring safe and effective treatment options to multiple myeloma patients around the world as early as possible,”said Charles Cai, MD, PhD, chief medical officer of Leads Biolabs, in a press release.

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

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