Revisit Every OncLive On Air Episode From January 2024

In case you missed it, below is a recap of every episode of OncLive On Air^® recorded in January 2024:

Santos Summarizes Key Updates From EMPOWER-Lung 1 and EMPOWER-Lung 3 With Cemiplimab in NSCLC

In an exclusive interview with OncLive^®, Edgardo S. Santos, MD, FACP, of Florida Atlantic University in Boca Raton, highlighted long-term follow-up findings from the phase 3 EMPOWER-Lung 3 trial (NCT03409614) of cemiplimab-rwlc (Libtayo) plus chemotherapy in patients with advanced non–small cell lung cancer (NSCLC); considerations for evaluating data from a subgroup analyses of the phase 3 EMPOWER-Lung 1 trial (NCT03088540) of cemiplimab monotherapy in patients with NSCLC and a PD-L1 score greater than 50%; and the ways that these data demonstrate the importance of conducting long-term follow-up analyses in clinical trials.

“EMPOWER-Lung 3…[established] one of the standards of care [(SOCs) for patients with advanced NSCLC] here in the United States…and longer follow-up [data] continue showing a striking difference in overall survival, also for [patients with] squamous cell histology,” Santos said in the episode.

FDA Approval Insights: Capivasertib Plus Fulvestrant in Advanced HR+/HER2- Breast Cancer With PIK3CA, AKT1, or PTEN Alterations

In November 2023, the FDA approved capivasertib (Truqap) plus fulvestrant (Faslodex) for patients with locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer with at least 1 PIK3CA, AKT1, or PTEN alteration whose disease has progressed on 1 or more endocrine-based regimens in the metastatic setting or who have experienced recurrence on or within 12 months of completing adjuvant therapy. The regulatory decision was backed by findings from the phase 3 CAPItello-291 trial (NCT04305496), in which treatment with the combination led to a median progression-free survival (PFS) of 7.3 months (95% CI, 5.5-9.0) vs 3.1 months (95% CI, 2.0-3.7) with placebo plus fulvestrant (HR, 0.50; 95% CI, 0.38-0.65; P < .0001).

In an exclusive interview with OncLive, William J. Gradishar, MD, of Northwestern University Feinberg School of Medicine in Chicago, Illinois, highlighted the significance of this approval, key efficacy and safety data from CAPItello-291, and how this combination may fit into the treatment paradigm for patients whose disease has progressed on a prior CDK4/6 inhibitor.

“Any new drug that’s available for treating breast cancer is welcome, and certainly within the realm of hormone-sensitive breast cancer, we’re always excited when we can have additional targeted therapies,” Gradishar emphasized in the episode. “We’ve moved along from giving endocrine therapy alone to partnering it with other agents to make them more effective or to delay or overcome resistance. Drugs like CDK4/6 inhibitors, mTOR inhibitors, etc. moved the field forward, and now with the PI3K inhibitor alpelisib [Vijoice] and the most recent one, capivasertib, we have many more drugs available to offer patients.”

Donington and Stiles Summarize NSCLC Resectability Parameters and Multidisciplinary Management

In an exclusive interview with OncLive, Jessica S. Donington, MD, MSCR, of the University of Chicago Comprehensive Cancer Center in Illinois, and Brendon M. Stiles, MD, of Montefiore Einstein Comprehensive Cancer Center in the Bronx, New York, spotlighted the implications of perioperative immunotherapy trials on early-stage disease management; discussed the definitions of resectability; and the incorporation of new guidance regarding multidisciplinary management according to the American Association of Thoracic Surgery, Society of Thoracic Surgeons, and National Comprehensive Cancer Network.

“Our practice is not to exclude patients from neoadjuvant or adjuvant therapy based on a low or negative PD-L1 score, but [regulatory] approvals are based on [PD-L1 score] in some places, so we probably need to find other biomarkers that may contribute or be added to PD-L1,” Stiles said in the interview.

“It’s going to be hard to keep up because all the guidelines [seem to be] changing by the week, but the indication for neoadjuvant therapy is clear and included in every guideline right now for stage II to IIIA disease,” Donington added.

Monk and Tarantino Describe the Investigation of B7-H4 Vedotin–Directed ADCs in Gynecologic and Breast Cancers

In this exclusive episode, Bradley J. Monk, MD, FACOG, FACS, of Florida Cancer Specialists & Research Institute in West Palm Beach, and Paolo Tarantino, MD, of the European Institute of Oncology in Milan, Italy, as well as of the Dana-Farber Cancer Institute in Boston, Massachusetts, spotlighted current research investigating B7-H4–directed antibody-drug conjugates (ADCs), including SGN-B7H4V and HS-20089, in multiple solid tumor types; highlighted several other promising ADCs in early development for gynecologic cancers; and speculated on future research needed to clarify unanswered questions regarding the optimal use and sequencing of ADCs in breast cancer.

“I’m excited about the [potential opportunity for vedotin ADCs to come to the clinic] because that linker and payload is established and FDA approved for several tumor types, so we have confidence about its activity and safety profile,” Monk emphasized in the episode.

“We’ve seen [success with] other ADCs with the vedotin payload, such as enfortumab vedotin-ejfv [Padcev] for the treatment of [patients with advanced bladder cancer] and tisotumab vedotin-tftv [(Tivdak) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy],” Tarantino added. “Now, this other vedotin ADC, [SGN-B7H4V], is showing promising activity.”

FDA Approval Insights: Nirogacestat in Progressing Desmoid Tumors Requiring Systemic Treatment

In November 2023, the FDA approved nirogacestat (Ogsiveo) for the treatment of adult patients with progressing desmoid tumors requiring systemic treatment. This regulatory decision was supported by data from the phase 3 DeFi trial (NCT03785964). In DeFi, the median PFS with nirogacestat was not reached (NR; 95% CI, NR-NR) vs 15.1 months (95% CI, 8.4-NR) with placebo (HR, 0.29; 95% CI, 0.15-0.55; P < .001).

In an exclusive interview with OncLive, Bernd Kasper, MD, PhD, of the Interdisciplinary Tumor Center Mannheim at Mannheim University Medical Center at the University of Heidelberg in Germany, highlighted the significance of this approval; key efficacy, safety, and quality-of-life outcomes from the DeFi trial; and findings from an analysis investigating tumor volume and T2 hyperintensity changes with nirogacestat in patients enrolled in DeFi that were presented at the 2023 ASCO Annual Meeting.

“Until now, we did not have any approved drugs in this indication, so nirogacestat is the first ever approved drug in this indication and is certainly the SOC for patients with desmoid tumors requiring systemic treatment,” Kasper highlighted in the episode.

Camidge and Leland Discuss the Road to a Multifaceted Biotechnology Career

In this exclusive installment of How This Is Building Me, host D. Ross Camidge, MD, PhD, spoke with Shawn Leland, PharmD, RPh, of Fore Biotherapeutics, to discuss the evolution of Dr Leland’s career, which included pursuing a PharmD degree, becoming a medical science liaison (MSL), and founding Elevation Oncology.

“We’re going to take the story of somebody who started off as a PharmD, went through being an MSL, and ended up being the chief executive officer of various things,” Camidge said in the episode.

“In my last year of pharmacy school, I found a potential path forward in industry, which is where I found myself gravitating toward,” Leland added.

Lunning and Maddocks Talk Through Frontline MCL Management

In this recent installment of The Blood Club, host Matthew Lunning, DO, FACP, of the University of Nebraska Medical Center in Omaha, was joined by Kami J. Maddocks, MD, of The Ohio State University Comprehensive Cancer Center––James in Columbus, to spotlight upfront mantle cell lymphoma (MCL) management, including findings from the phase 3 SHINE (NCT01776840) and TRIANGLE (NCT02858258) trials; the ways these trial data have altered the role of first-line BTK inhibitors in chemotherapy-free regimens for patients with MCL; and how patient characteristics affect up-front treatment feasibility.

“MCL represents only approximately 5% of non-Hodgkin lymphomas, and when it’s diagnosed, even out in the community, there’s a sense of confusion about the diagnosis and how to manage it,” Lunning noted in the episode.

“The TRIANGLE data that read out at the 2023 ASH Annual Meeting were exciting because it solidified [a place for BTK inhibitors] in the frontline treatment [of patients with MCL],” Maddocks added.

FDA Approval Insights: Pirtobrutunib in Previously Treated CLL/SLL

In December 2023, pirtobrutinib (Jaypirca) received accelerated approval from the FDA for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a BCL-2 inhibitor and a BTK inhibitor. This regulatory decision was backed by results from the CLL/SLL cohort (n = 108) of the phase 1/2 BRUIN trial (NCT03740529), in which the agent elicited an overall response rate of 72% (95% CI, 63%-80%).

In an exclusive interview with OncLive, Matthew S. Davids, MD, MMSc, of Dana-Farber Cancer Institute, highlighted he significance of this approval, key data from BRUIN, and guidelines for pirtobrutinib use in the CLL/SLL patient population.

“These patients tend to have poor outcomes with other standard therapies,” Davids explained in the episode. “[Having] seen the promising data with pirtobrutinib coming out over the past couple years, it’s exciting to see this drug now approved for this patient population.”

Expert and Patient Perspectives on AE Management With FGFR Inhibitors in Cholangiocarcinoma

In an exclusive OncLive Insights webinar, Lipika Goyal, MD, of Stanford Medicine in California, moderated a discussion about the optimal use of FGFR inhibitors in patients with cholangiocarcinoma and considerations for moderating adverse effects (AEs) in this patient population.

“Because these are oral agents that patients can take at home, they have the impression they’ll be easier to tolerate than therapy they may have received previously,” Caroline Kulhman, NP,Massachusetts General Hospital in Boston, emphasized in the conversation. “Discuss that there are real AEs associated with these drugs. [These AEs] can be mild, but they can also be severe, and they can affect many body systems.”

“We haven’t seen too many serious AEs that are truly causally related to the drugs,” Katie Kelley, MD, of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, added. “We’ve had a couple patients with rashes that are grade 3 or potentially hypersensitivity-type reactions, but those are rare.”

“The discussion around AEs was most thorough between my care team and I when I was part of a clinical trial,” Chaundra Bishop, a patient with cholangiocarcinoma, shared. “They took a lot of time to help me understand the most common AEs and some that weren’t as common. Meanwhile, with the standard chemotherapies, [these AE discussions] were somewhat breezed through. These [constituted] less robust conversations around AEs. Even though these AEs are mentioned, we don’t discuss a lot about how they will manifest.”

“It’s certainly not enough to [tell patients their] phosphorous levels might increase or they might experience some nail changes,” Goyal concluded. “Going into specifics about what that means for [the patient’s] life, how they will feel, what the treatments will be, and what [AEs] to look out for specifically is more helpful than a laundry list of possible AEs.”