Oncology News Central Peer-Spectives

FDA Approvals, Pivotal Trial Data Change Approach to Breast Cancer Progression

Recent approvals by the U.S. Food and Drug Administration (FDA) and findings from pivotal clinical trials have changed care for patients with breast cancer that has progressed after frontline hormone therapy. Ruth M. O’Regan, MD, chair of medicine and Charles H. Dewey Professor at the University of Rochester in New York, highlights which recent developments regarding second- and third-line treatments are most essential. She and Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai Cancer Center in Los Angeles, discuss which newly approved drugs are making a difference in patients with actionable mutations, as well as those without. Dr. O’Regan also details which soon-to-be reported studies she is awaiting in 2024.

Controversies, Difficult Questions Arise in NSCLC Amid New Data

Recent data on the use of immunotherapy and targeted treatments in patients with advanced non-small cell lung cancer (NSCLC) have introduced a myriad of questions. These include controversial topics and difficult decisions, like when to incorporate CTLA-4 inhibition and what patients can expect from immuno-oncology monotherapy in the metastatic setting. Edward B. Garon, MD, MS, professor in the department of medicine in hematology/oncology and director of the thoracic oncology program at the Jonsson Comprehensive Cancer Center at the University of California Los Angeles, discusses key challenges in NSCLC care with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai Cancer Center in Los Angeles. From optimal strategies in second-line settings to promising clinical trials, Dr. Garon shares how he applies emerging information in practice.  

What FDA Approval of Belzutifan Means for Kidney Cancer Care

Belzutifan was recently approved by the U.S. Food and Drug Administration (FDA) for use in previously treated adults with advanced renal cell carcinoma. How should this drug best be incorporated into practice? Eric Jonasch, MD, professor in the Department of Genitourinary Medical Oncology at the University of Texas MD Anderson Cancer Center in Houston, and Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai Cancer Center in Los Angeles, discuss how the medication might be used in clinic. Dr. Jonasch also provides insight into the LITESPARK-005 study, which led to the FDA approval, as well as other ongoing trials that may further change the landscape of kidney cancer care.

Despite Lack of Head-to-Head Trials, Practice Patterns Shifting in Breast Cancer

CDK4/6 inhibitors “have really been a game changer” in metastatic breast cancer, according to Komal Jhaveri, MD, clinical director for early drug development and section head for endocrine therapy research at Memorial Sloan Kettering in New York City. However, optimal treatment strategies have been complicated by a lack of head-to-head trials. Dr. Jhaveri speaks with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai Cancer Center in Los Angeles, about how “practice patterns have slightly shifted” despite challenges in assessing efficacy across regimens and approaches. Dr. Jhaveri also discusses her work on the INAVO120 study, which found a benefit in adding a PI3K inhibitor to the combination of CDK4/6 inhibitors and hormone therapy. The trial reported a “monstrously important clinical hazard ratio,” according to Dr. Figlin, and may help clarify best practices moving forward.

Which FDA Approvals, Other Advances Changed ER-Positive Breast Cancer Care in 2023?

From compelling data presented at the San Antonio Breast Cancer Symposium to the recent U.S. Food and Drug Administration approval of capivasertib, 2023 saw numerous key advances in breast cancer care. Aditya Bardia, MD, MPH, director of the breast cancer research program at Massachusetts General Hospital and associate professor at Harvard Medical School in Boston, and Robert A. Figlin, MD, the Steven Spielberg Family Chair in hematology-oncology at Cedars-Sinai Cancer Center in Los Angeles, discuss how several notable developments are already impacting practice. Dr. Bardia explains why genotyping is essential, provided it is available and affordable, and what recent changes have meant for the “roadmap” he presents to patients with metastatic disease. He also considers what 2024 may have on tap for this rapidly changing field.

“New Disruptor” in Prostate Cancer: PSMA PET and Other Treatment Advances

From the use of prostate-specific membrane antigen (PSMA) positron-emission tomography (PET) to advancements in targeted treatments, prostate cancer care is quickly evolving. Edwin M. Posadas, MD, director of the Experimental Therapeutics Program and director of the Center for Urologic Oncology Research Excellence at Cedars-Sinai in Los Angeles, speaks with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai, about how he is already implementing promising new data into practice. Although Dr. Posadas notes that although immunotherapy approaches in prostate cancer have been “a bit of a disappointment” so far, he sees “a lot of exciting research going on.” He explains why he doesn’t “like to wait” when expanding his therapeutic armamentarium and why he prefers to be “proactive rather than reactive” when it comes to molecular profiling and other approaches.

Practice-Changing Results in Prostate Cancer, as Enzalutamide Regimens Show Strong Benefit

Results of the recent EMBARK study show that both enzalutamide plus leuprolide and enzalutamide monotherapy significantly improved metastasis-free survival compared with leuprolide alone in patients with prostate cancer who have high-risk biochemical recurrence. Lead author Stephen Freedland, MD, associate director for education and training and director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer Center in Los Angeles, speaks with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai, about how these findings should be applied in practice. Although the data represent a significant advance, Dr. Freedland suggests even more progress ahead, asking "This is the new standard, but for those [who] are really high-risk, how can we do even better?”

ER-Positive Breast Cancer Advances and Other Eagerly Anticipated Data at SABCS 2023

Studies involving high-risk, early-stage ER-positive breast cancer are among the most eagerly anticipated at this year’s San Antonio Breast Cancer Symposium (SABCS), to be held Dec. 5-9. Virginia Kaklamani, MD, professor of medicine in the division of hematology and medical oncology at the University of Texas Health Sciences Center San Antonio and leader of the breast cancer program at the Mays Cancer Center, discusses which data she thinks has the best chance of changing practice soon. She also speaks with Bob Figlin, MD, the Steven Spielberg Family Chair in hematology-oncology at Cedars-Sinai Cancer Center in Los Angeles, about key research into HER2-positive disease, brain metastases, and local therapy to watch for at this year’s conference.

Inside ODAC’s Vote on Sotorasib in Advanced and Metastatic NSCLC: Lessons Learned

Last month, a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) determined that progression-free survival (PFS) could not be reliably interpreted in a confirmatory clinical trial for sotorasib (Lumakras) used to treat KRAS G12C–mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Ravi A. Madan, MD, senior clinician at the National Cancer Institute’s Center for Cancer Research and chair of the ODAC, speaks with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai Cancer Center in Los Angeles, about broader implications from the 2-10 vote against the sotorasib data. They discuss the specific rationale behind the decision, as well as what this means for clinical practice in the short term and big picture solutions to help improve future trials.

First-Line Osimertinib Plus Chemo in NSCLC: How to Weigh Toxicity vs. Efficacy

How should results of the FLAURA2 clinical trial be applied in practice? The study examined the use of osimertinib plus chemotherapy in the first-line treatment of EGFR-mutated advanced non-small cell lung cancer (NSCLC) compared with osimertinib alone and found that progression-free survival was significantly improved with the combination treatment. Pasi A. Jänne, MD, PhD, director of three cancer centers at the Dana-Farber Cancer Institute in Boston, including the Lowe Center for Thoracic Oncology, shares his team’s findings with Bob Figlin, MD, the Steven Spielberg Family Chair in hematology-oncology at Cedars-Sinai Cancer Center in Los Angeles. They discuss toxicity concerns, best practices for treatment assessment, and how to identify patients for whom the new strategy may yield the best results.