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T-DXd showcased overall and intracranial activity in patients with HER2-positive metastatic breast cancer with stable and active brain metastases.

DESTINY-Breast12 Data Support T-DXd Use in HER2+ Breast Cancer, Irrespective of Brain Mets 

The addition of nivolumab to tivozanib did not improve outcomes in metastatic RCC and 1.34 mg of tivozanib monotherapy may be considered as a second-line therapy. 

Tivozanib Monotherapy Bests Lower-Dose Tivozanib Plus Nivolumab in Metastatic RCC 

BMS-986012 plus nivolumab and chemotherapy provided a modest PFS benefit but signals of OS improvement in extensive-stage small cell lung cancer. 

Frontline BMS-986012 Plus Nivolumab/Chemotherapy Shows Promise in ES-SCLC

Belzutifan improved PFS and ORR but failed to deliver a significant improvement in OS vs everolimus in pretreated advanced clear cell renal cell carcinoma. 

Belzutifan Maintains PFS, ORR Benefits in Previously Treated Advanced Clear Cell RCC 

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Ashling Wahner joined MJH Life Sciences in 2022. She produces 

, and helps ensure timely publication of news content and announcements from the FDA approval pipeline. She also attends conferences live and virtually to conduct video interviews and produce written coverage. Email: awahner@mjhlifesciences.com

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 as an assistant editor in October 2022. Leveraging an educational background in the life sciences and prior experience conducting interviews in a university setting, she plays a key role in shaping social media strategy, covering live conferences, and producing multimedia content for both print and digital platforms. Email: 

Findings from a molecular analysis of the CoMMpass study identified copy number and expression subtypes of high-risk, newly diagnosed multiple myeloma.

Myeloma Molecular Profiling Reveals Unique Copy Number and Expression Subtypes

 
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource 

. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

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™. She joined the company in 2018 as an assistant editor, with expertise in video production and print/digital publication. Email: cseymour@onclive.com​ 

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, aiding in all aspects of the publication process, as well as content for OncLive.com.

 in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: chryan@onclive.com


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Frank A. Sinicrope, MD, medical oncologist, Departments of Gastroenterology and Hepatology and Oncology, Mayo Clinic, discusses patients with metastatic colorectal cancer (mCRC) who are mismatch repair-deficient. 


Dr. Sinicrope on Mismatch Repair-Deficient Patients With Metastatic Colorectal Cancer

Brigatinib in NF2-Related Schwannomatosis with Progressive Tumors

Scott Plotkin, MD, reviews data from a phase II study on brigatinib, a multi tyrosine kinase inhibitor, across various tumor types in patients with NF2-related schwannomatosis.

Long-term Follow-up of Selinexor Maintenance for Patients With TP53wt Advanced or Recurrent Endometrial Cancer: A Prespecified Subgroup Analysis From the Phase 3 ENGOT-EN5/GOG-3055/SIENDO Study

David Miller, MD, reviews a plenary presentation (originally presented at the ASCO 2024 Annual Meeting by Vikky Makker, MD) on the long-term follow-up of the ENGOT-EN5/GOG-3055/SIENDO trial, focusing on selinexor maintenance for patients with TP53 wild-type advanced or recurrent endometrial cancer.

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Dr Rafiq on Novel Strategies for CAR T-Cell Engineering in Solid Tumors

Sarwish Rafiq, PhD, assistant professor, Department of Hematology and Medical Oncology, Emory University School of Medicine; program leader, CAR T Basic/Translational Research, Winship Center for Cancer Immunology, Winship Cancer Institute of Emory University, discusses how novel methods for engineering metabolically fit, memory rich CAR T-cells may address barriers to CAR T-cell efficacy in solid tumors.

At the Frontiers in Cancer Immunotherapy 2024 Symposium, Rafiq presented and shared 2 novel approaches to CAR T-cell engineering. The first multi-cytokine particle approach is a CAR T-cell extrinsic method, which involves engineering microparticles to enhance the manufacturing process of CAR T cells, Rafiq states. Since CAR T cells are extracted from patients, modified ex vivo, and then reinfused, this approach focuses on improving the quality of the cells during the manufacturing stage, she details. The engineered microparticles help in enriching the cells for memory phenotypes, which are associated with more durable responses in patients, Rafiq explains.

The second approach is a T-cell intrinsic method where CAR T cells are engineered to secrete their own antagonistic peptide against a novel immune checkpoint, Rafiq says. This modification alters the metabolism and activation profile of the CAR T cells, resulting in a more potent product, she describes.

Before these approaches can be used to manufacture CAR T cells for patients, additional GMP grade studies are needed, Rafiq continues. These studies will indicate whether the extrinsic approach can be implemented in a manufacturing facility to produce CAR T cells. For the intrinsic approach involving vasoactive intestinal peptide receptor antagonists, current research is focused on syngeneic mouse models, which involve the use of mouse CAR T cells in mice that have an intact immune system and tumors, Rafiq says. This research aims to determine if an endogenous immune response can be engaged and to assess any potential on-target off-tumor toxicities from antagonizing the receptor, she explains.

Additionally, studies addressing toxicity with the secreting CAR T cells are necessary to ensure their safety for patients, Rafiq notes. These steps are crucial for advancing these innovative CAR T-cell approaches from experimental stages to clinical application, she concludes.

Sarwish Rafiq, PhD, discusses how engineering metabolically fit, memory rich CAR T-cells may address barriers to CAR T-cell efficacy in solid tumors.

Perioperative chemotherapy with docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (FLOT protocol) led to a significant overall survival (OS) benefit vs neoadjuvant chemoradiation (CROSS protocol) in patients with resectable esophageal cancer

 according to findings from the phase 3 ESOPEC trial (NCT02509286) presented during the 

At a median follow-up of 55 months, patients in the intention-to-treat population who received the FLOT protocol (n = 221) achieved a median OS of 66 months (95% CI, 36-not evaluable [NE]) compared with 37 months (95% CI, 28-43) among those who were treated with the CROSS protocol (n = 217; HR, 0.70; 95% CI, 0.53-0.92; 

 = .012). The 3-year OS rates were 57.4% vs 50.7%, respectively, and the 5-year OS rates were 50.6% vs 38.7%, respectively.

Additionally, the median progression-free survival (PFS) was 38 months (95% CI, 21-NE) in the FLOT arm compared with 16 months (95% CI, 12-22) in the CROSS arm (HR, 0.66; 95% CI, 0.51-0.85; 

 = .001). The 3-year PFS rates were 51.6% vs 35.0%, respectively, and the 5-year PFS rates were 44.4% vs 30.9%, respectively.

“Many patients in the US and Europe are still treated with the CROSS radiochemotherapy protocol. Our study shows that patients with resectable esophageal cancer should have FLOT chemotherapy before and after the operation in order to optimize the chance of curing their tumors in the long term,” Jens Hoeppner, FAChirg, FACS, MD, the director of the Department of Surgery at University Medical Center, University of Bielefeld, in Detmold, Germany, stated in a press release.

ESOPEC was a prospective multicenter study that enrolled patients with esophageal adenocarcinoma across 25 sites in Germany between February 2016 and April 2020. Eligible patients needed to be at least 18 years old, have received no prior abdominal or thoracic radiotherapy, have an ECOG performance status of 2 or less, and have adequate organ function. Patients were also required to have pretreatment stage cT1N+, M0 or cT2-4a, N0/+, M0 disease. The presence of squamous or other non-adenocarcinoma histology, gastric cancer, clinical stage cT1cN0 and cT4b disease, or metastatic disease excluded patients from enrollment.

Patients were randomly assigned 1:1 to receive either the FLOT or CROSS protocol. Those in the FLOT arm received repeated doses of 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel every 2 weeks over 4 neoadjuvant cycles prior to surgery and 4 adjuvant cycles after surgery. In the CROSS arm, patients received neoadjuvant radiation therapy and concurrent chemotherapy with carboplatin and paclitaxel for 5 cycles in 5 weeks prior to surgery. Following neoadjuvant treatment, patients in both arms waited 4 to 6 weeks before proceeding to surgery. 

The primary end point was OS. Secondary end points included PFS, recurrence-free survival, postoperative pathological stage, postoperative complications, and postsurgical quality of life.

At baseline, the mean age of patients in the FLOT and CROSS arms was 63.1 years (standard deviation [SD], 8.6) vs 62.6 years (SD, 9.8), respectively. Most patients in both arms were male (89.1% vs 89.4%), had clinical T-stage cT3-4 disease (79.1% vs 81.9%), and had clinical N-stage cN+ disease (77.8% vs 81.6%). Overall, 191 patients in the FLOT arm underwent surgery compared with 180 patients in the CROSS arm.

Additional findings from ESOPEC showed that the pathological complete remission rates among patients who underwent surgery in the FLOT arm was 16.8% compared with 10.0% in the CROSS arm. In both arms, complete regression (18.3% vs 13.3%) or near complete regression (25.1% vs 39.4%) was observed. Most patients across both arms underwent an R0 resection (94.2% vs 95.0%).

Patients in the predefined protocol population in the FLOT (n = 207) and CROSS (n = 196) arms achieved a median OS of 66 months (95% CI, 38-NE) vs 39 months (95% CI, 29-45), respectively (HR, 0.72; 95% CI, 0.54-0.96; 

 = .023). The 3-year OS rates were 58.1% vs 52.6%, respectively, and the 5-year OS rates were 51.8% vs 40.5%, respectively.

Results from an exploratory subgroup analysis demonstrated that the OS benefit in favor of FLOT vs CROSS was observed in all subgroups examined. The most pronounced benefit was reported in patients aged less than 60 years (HR, 0.57; 95% CI, 0.34-0.95) and those with clinical T-stage T3-4 disease (HR, 0.68; 95% CI, 0.50-0.92).

Most patients in both the FLOT and CROSS arms started neoadjuvant treatment; these patients comprised the predefined protocol population. A majority of patients in both arms completed neoadjuvant treatment (87.3% vs 67.7%) and received neoadjuvant treatment plus surgery (86.0% vs 82.9%). In the FLOT arm, 63.3% of patients received adjuvant treatment and 52.5% completed adjuvant treatment.

In the 90 days post-surgery, 3.2% of patients in the FLOT arm died compared with 5.6% in the CROSS arm. The 30-day postoperative mortality rates were 1.0% vs 1.7%, respectively At the data cutoff, 97 and 121 patients died in these respective arms.

“Perioperative chemotherapy with FLOT plus surgery improves OS compared with neoadjuvant chemoradiation with CROSS plus surgery in patients with locally advanced, resectable esophageal adenocarcinoma. ESOPEC found that perioperative chemotherapy with FLOT should be preferred over neoadjuvant chemoradiation with the CROSS protocol for improving survival in resectable esophageal adenocarcinoma,” Hoeppner concluded in an oral presentation. 

Hoeppner J, Brunner T, Lordick F, et al. Prospective randomized multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (ESOPEC trial).

. 2024;42(suppl 17):LBA1. doi:10.1200/JCO.2024.42.17_suppl.LBA1

Chemotherapy before and after surgery may be new standard treatment for some patients with esophageal cancer. News Release. ASCO. June 2, 2024. Accessed June 2, 2024. https://society.asco.org/about-asco/press-center/news-releases/chemotherapy-and-after-surgery-may-be-new-standard-treatment

Perioperative chemotherapy compared to neoadjuvant chemoradiation in patients with adenocarcinoma of the esophagus (ESOPEC). ClinicalTrials.gov. Updated May 8, 2024. Accessed June 1, 2024. https://clinicaltrials.gov/study/NCT02509286

 study was published on June 2, 2024, from the press briefing, and was updated on June 4, 2024, with additional information/data from the oral session.

Perioperative chemotherapy using the FLOT protocol demonstrated a significant overall survival benefit over neoadjuvant chemoradiation (CROSS protocol) in patients with resectable esophageal cancer, as evidenced by the phase 3 ESOPEC trial. With a median follow-up of 55 months, the FLOT protocol achieved a median overall survival of 66 months compared to 37 months with the CROSS protocol. The study suggests that FLOT chemotherapy before and after surgery should be considered to optimize long-term tumor cure rates in these patients.

Perioperative chemotherapy with FLOT improved OS vs neoadjuvant chemoradiation with CROSS in resectable esophageal cancer.

Conference

Perioperative Chemotherapy Prolongs OS vs Neoadjuvant Chemoradiation in Esophageal Cancer

Welcome to OncLive On Air®! I’m your host today, Jax DiEugenio.

OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we invited experts from across oncology specialties to discuss the abstracts and presentations they are most looking forward to seeing at the 2024 ESMO Congress.

Emre Yekedüz, MD, an associate professor of medical oncology at Ankara University in Turkey and a research fellow at Dana-Farber Cancer Institute in Boston, Massachusetts, shared insights on his latest work in genitourinary malignancies, particularly muscle-invasive bladder cancer. 

Thach-Giao Truong, MD, a hematologist and medical oncologist at the Cleveland Clinic in Ohio who specializes in skin cancers including basal cell carcinoma, melanoma, and Merkel cell carcinoma, highlighted her recent findings in targeted therapies for advanced skin cancers.

John H. Strickler, MD, an associate professor of medicine in the Division of Medical Oncology at Duke University in Durham, North Carolina, emphasized key updates in the treatment of gastroesophageal malignancies, where he sees significant progress on the horizon.

David Spigel, MD, chief scientific officer and medical oncologist at Sarah Cannon Research Institute in Nashville, Tennessee, discussed the expanding lung cancer clinical trial program he oversees, ensuring patients have access to cutting-edge therapies.

Finally, Paolo Tarantino, MD, a researcher at the European Institute of Oncology and clinical research fellow at Dana-Farber Cancer Institute, focused on advancements in breast cancer research, particularly in HER2-targeted therapies and antibody-drug conjugates.

That’s all we have for today! Thank you for listening to this episode of OncLive On Air. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

For more updates in oncology, be sure to visit 

OncLive is also on social media. On Twitter, follow us at @OncLive. On Facebook, like us at OncLive, and follow our OncLive page on LinkedIn.

If you liked today’s episode of OncLive On Air, please consider subscribing to our podcast on Apple Podcasts, Spotify, Google Podcasts, Amazon Music, and many of your other favorite podcast platforms,* so you get a notification every time a new episode is posted. While you are there, please take a moment to rate us!

Thanks again for listening to OncLive On Air.

Experts from across oncology specialties discuss the abstracts and presentations they are most looking forward to seeing at the 2024 ESMO Congress.

Conference Perspectives

Oncology Experts Preview Top Abstracts From the 2024 ESMO Congress 

Dr. Gordon was contracted with Bristol Myers Squibb for this article but did not receive any compensation for sharing his perspective for this story

Chimeric antigen receptor (CAR) T cell therapy is a personalized approach to treating certain blood cancers and is one of the most impactful advances in immunotherapy care seen in the last 20 years. CAR T cell therapy works by leveraging the immune system’s inherent ability to fight cancer, genetically engineering a patient’s own T cells to recognize and bind to proteins found on the surface of certain cancer cells. This interaction leads to the activation of the CAR T cells, which can then kill their target cells and continue to multiply within the body.

There are currently six U.S. Food and Drug Administration (FDA) approved CAR T cell therapies, each targeting B-cell markers CD19 or BCMA and indicated to treat select blood cancers. Investigational CAR Ts that recognize new targets and multiple antigens at once are also being developed to help expand cell therapy beyond blood cancers.

Leo Gordon, MD, is a professor of medicine in hematology and oncology at Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center. He has seen the clinical development of CAR T treatments as a result of clinical research and is a passionate advocate for making cell therapies available for appropriate patients.

“Between my research and clinical activities, I have witnessed first-hand what CAR T cell therapies are capable of delivering, especially for patients that have run out of viable treatment options,” said Dr. Gordon. “Lymphoma, in particular, is an area where CAR T cell therapies have resulted in significant responses and long remissions, improving outcomes for patients who had limited options just five years ago.”

The promise and future of cell therapy in treating relapsed or refractory LBCL

Large B-cell lymphoma (LBCL) is a form of non-Hodgkin’s lymphoma that comprises about 30% of all non-Hodgkin’s lymphoma cases and is diagnosed in approximately 150,000 people worldwide annually.

 Roughly 60% of patients with LBCL achieve long-term remission with initial chemoimmunotherapy, leaving as many as 40% that do not respond or relapse after treatment.

Typical second-line treatments, including high-dose chemotherapy and stem-cell transplantation, can improve outcomes; however, patients who are resistant to initial treatment or relapse early often fail to achieve long-term benefits.

 Therefore, personalized therapy options have been approved for patients with relapsed or refractory (R/R) LBCL.

CD19 is a critical target as it is broadly expressed among many B-cell malignancies, including LBCL. With CD19-targeting CAR T cell therapies, T cells are genetically reprogrammed to help recognize and target CD19-expressing cells, which may include healthy and cancerous cells.

“The availability of a CAR T cell therapy as a second-line treatment is crucial, as some types of large B-cell lymphoma quickly worsen, and patients can’t afford to wait before finding a promising option,” said Dr. Gordon. “CAR T cell therapy is a personalized treatment for patients with certain relapsed or refractory blood cancers. Fortunately, CAR T cell therapies are available for relapsed or refractory large B-cell lymphoma patients earlier in the treatment journey, like 

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:

refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or

refractory disease to first-line chemoimmunotherapy or relapse after first line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or

relapsed or refractory disease after two or more lines of systemic therapy.

Please see the Important Safety Information section below, on serious side effects including Boxed WARNINGS for 

regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities (NT), and Secondary Hematologic Malignancies.

Serious side effects such as CRS, NT, hypersensitivity reactions, severe infections, including life-threatening or fatal infections, prolonged cytopenias, hypogammaglobulinemia, secondary hematological malignancies and effects on the ability to drive and use machines may occur with 

include fever, fatigue, musculoskeletal pain, and nausea.

was first approved for use later in a patient’s treatment journey, after two or more lines of systemic therapy. A few years later, the FDA approved it as a second-line treatment based on results from the TRANSFORM and PILOT clinical trials.

TRANSFORM is a pivotal, global, randomized, open-label multicenter Phase 3 trial evaluating 

compared to current standard therapy regimens (platinum-based salvage chemotherapy followed by high-dose chemotherapy and autologous HSCT in patients responding to salvage chemotherapy) in adult patients with LBCL that was primary refractory or relapsed within 12 months after first-line chemoimmunotherapy.

In the TRANSFORM study (n=184), at interim analysis after a median follow-up of 6.2 months, median event-free survival (mEFS) was 10.1 months for 

 vs 2.3 months for standard therapy, a 4x improvement.

CAR T cell therapies have shown remarkable clinical success in difficult-to-treat blood cancers. Read one oncologist’s perspective on what current CAR T therapies may offer patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), including at earlier points in their disease journey.

Frank A. Sinicrope, MD

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