Oncology News Central Peer-Spectives

“Cancer clinical research has been largely privatized,” explains Joseph Unger, PhD, MS, associate professor in the cancer prevention program at the Fred Hutchinson Cancer Center in Seattle. Dr. Unger and colleagues recently assessed patient enrollment in industry-sponsored and federally sponsored clinical trials. They found an 8:1 ratio favoring participation in research backed by industry. This raises significant concerns, he tells Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles. Dr. Unger explains what he sees as the root causes for the current imbalance, potential negative effects, and possible solutions for how to “rebalance the portfolio.” “I’m doing whatever I can to help illustrate what the issues are through my research,” he notes. Dr. Unger reported a consulting/advisory role with AstraZeneca and Loxo/Lilly. Dr. Figlin reported various financial relationships.

Treatment approaches for patients with hormone receptor (HR)-positive, HER2-negative breast cancer have rapidly evolved, thanks in part to data from three key studies. Erin Frances Cobain, MD, associate professor at the University of Michigan Rogel Cancer Center in Ann Arbor, explains how findings from the KEYNOTE-756, monarchE, and NATALEE clinical trials are influencing decision-making for these patients. She and Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles, discuss the evolving role of immunotherapy and how to choose between CDK4/6 inhibitors, given the recent U.S. Food and Drug Administration approval of adjuvant ribociclib for patients with early breast cancer who are at high risk for recurrence. Dr. Cobain acknowledges that these and other findings have led to “challenging discussions,” even if those conversations are ultimately beneficial. Dr. Cobain reported various financial relationships. Dr. Figlin reported various financial relationships.

Approvals of antibody-drug conjugates (ADCs) for metastatic breast cancer have introduced complex questions about HER2 expression. “It’s certainly been a changing landscape, which has been confusing for all of us,” explains Ian Krop, MD, PhD, director of the clinical trials office, chief clinical research officer, and associate director for clinical sciences at Yale Cancer Center in New Haven, Connecticut. He and Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles, discuss how oncologists should best approach HER2 testing, ADC sequencing, and toxicity concerns. When it comes to answering key questions, “We're a little data-poor in some ways because this is such a rapidly evolving field,” Dr. Krop explains. He also considers what’s next for ADCs in breast cancer, including the potential for those treatments to move into the curative early-disease setting. Dr. Krop reported various financial relationships.  Dr. Figlin reported various financial relationships.

Newly approved targeted therapies for patients with advanced hormone receptor (HR)-positive, HER2-negative breast cancer are changing care. “We have an abundance of opportunities, but challenges with having to choose the right opportunity at the right time,” says Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles. Dr. Figlin discusses how to navigate new options with Manali Bhave, MD, a breast medical oncologist and assistant professor at the Emory University School of Medicine in Atlanta. Dr. Bhave stresses that disease progression in breast cancer can’t be addressed with a one-size-fits- all option. “Where do we go from here? I think it is largely dependent on clinical factors, patient comorbidities, and even biomarker status,” she explains. Dr. Bhave and Dr. Figlin discuss recent developments in targeted therapies and important challenges. “We’ve come a long way in treating metastatic HR-positive, HER2-negative breast cancer as more of a chronic disease,” she says. Dr. Bhave reported consulting fees from Lilly, Novartis, and AstraZeneca. Dr. Figlin reported various financial relationships.

Data on the use of durvalumab after chemoradiotherapy transformed the standard of care for patients with unresectable stage III non-small cell lung cancer (NSCLC). “This is a real practice-changing observation from the PACIFIC trial,” said Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles. He recently spoke with Meghan Mooradian, MD, an instructor at Harvard Medical School in Boston, about her team’s recent research assessing the protocol established by the PACIFIC study. “We really are hoping for a cure,” she said in describing how she makes decisions related to the timing of durvalumab after chemoradiotherapy. Dr. Mooradian also addressed toxicity concerns and shared what she sees as lingering questions related to disease progression. “What should we really be using next?” she asked. Dr. Mooradian reported consulting or advisory roles with AstraZeneca, the Bristol Myers Squibb Foundation, Istari Oncology, Regeneron, and Xilio Therapeutics; and other relationships with Aptitude Health, Curio Science, DAVA Oncology, and OncLive/MJH Life Sciences. Dr. Figlin reported various financial relationships.

Results of the phase 3 LAURA clinical trial, presented at the 2024 American Society of Clinical Oncology Annual Meeting, showed that osimertinib significantly improves progression-free survival in patients with unresectable stage III EGFR-mutant non-small cell lung cancer (NSCLC) after chemoradiotherapy. “The benefits of osimertinib in this patient population when compared to placebo are just incredibly dramatic,” noted Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles. He spoke with lead study author Suresh S. Ramalingam, MD, the Roberto C. Goizueta Distinguished Chair for Cancer Research and the executive director at the Winship Cancer Institute of Emory University in Atlanta, about how oncologists should adjust their practice in the wake of these key findings. Dr. Ramalingam tackled questions about the optimal duration of osimertinib therapy, toxicity concerns, and notable benefits seen in the LAURA data. “Osimertinib reduced both intrathoracic progression and extrathoracic progression, particularly intracranial progression,” he noted. Dr. Ramalingam reported research funding from Amgen, AstraZeneca/MedImmune, Bristol Myers Squibb, Merck, Pfizer, and Takeda; travel, accommodations, and other expenses from AbbVie; and a relationship with the American Cancer Society. Dr. Figlin reported various financial relationships.

“I think the antibody-drug conjugates (ADCs) for physicians, and certainly patients too, are a little bit tough to wrap your head around,” says Erika P. Hamilton, MD, the director of breast cancer and gynecologic cancer research at Sarah Cannon Research Institute in Nashville. She discusses how TROP2-targeting ADCs currently fit into practice with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles. From how to “choose the right patient for the right treatment at the right time” to important toxicity concerns, Dr. Hamilton shares her “elevator pitch” to patients when it comes to ADCs. “I think a very easy way to really talk about the activity at this point is just the fact that they’re beating naked chemotherapy. So they are performing better than chemotherapy and, for the most part, comparing favorably in terms of side effects for patients as well.” Dr. Hamilton reported various financial relationships. Dr. Figlin reported various financial relationships.

Various survivorship guidelines for pediatric patients have been established, but “such guidelines do not exist in the adult world,” says Smita Bhatia, MD, MPH, director of the Institute for Cancer Outcomes and Survivorship and the Gay and Bew White Endowed Professor in Pediatric Oncology at the University of Alabama at Birmingham. With the number of adult cancer survivors rapidly rising, the time is now for major oncology societies to help create long-term health recommendations, she tells Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles. Dr. Bhatia and Dr. Figlin discuss the critical need to explore how recent advances in cancer care, such as targeted treatments and immunotherapies, may affect the future health of survivors. “If we don’t start by constructing large cohorts and following them long term, we will have lost this opportunity that exists right now,” she explains. Dr. Bhatia is an Associate Editor for Journal of Clinical Oncology. Journal policy recused the author from having any role in the peer review of the manuscript discussed. Dr. Figlin reported various financial relationships.

Obstacles to “achieving a good, peaceful death” prevent many patients with cancer from the “dignified end” that they deserve, says Sunita Puri, MD, a palliative care physician and author. She and Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles, discuss frustrations and concerns about systemic failures in cancer care when it comes to death and dying. “We need to have this national dialogue around this topic,” argues Dr. Figlin. “It can’t be under the covers, where we don’t talk about it.” Dr. Puri reported no relevant financial disclosures. Dr. Figlin reported various financial relationships.

When it comes to the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL), "within the last eight months or so, we have had some exciting new events," says Daniel A. Ermann, MD, a hematologist-oncologist and assistant professor at the University of Utah Huntsman Cancer Institute in Salt Lake City. The U.S. Food and Drug Administration approved pirtobrutinib for previously treated CLL in December 2023 and approved the CAR-T therapy lisocabtagene ciloleucel for relapsed/refractory disease in March 2024. These new options for patients with unmet needs present "a difficult choice, and it is a little bit of a balance," Dr. Ermann explains. He discusses key considerations for treatment selection with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at the Cedars-Sinai Cancer Center in Los Angeles.