© 2023 HSP News Service, L.L.C.
On May 19, 2023, epcoritamab-bysp was granted accelerated approval by the U.S. Food and Drug Administration for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two ...
As reported in The Lancet Oncology by Jianming Xu, MD, of Fifth Medical Center, Chinese PLA General Hospital, Beijing, corresponding author Harry H. Yoon, MD, of the Department of Oncology, Mayo Clinic, Rochester, and colleagues, an interim analysis of the phase III RATIONALE-306 trial has shown...
In the Spanish phase II NADIM II trial reported in The New England Journal of Medicine, Mariano Provencio, MD, PhD, and colleagues found that the addition of nivolumab to platinum-based chemotherapy improved pathologic complete response (pCR) rates among patients with resectable stage IIIA or IIIB...
As reported in the Journal of Clinical Oncology by O’Donnell et al, findings in a cohort of the phase Ib/II EV-103/KEYNOTE-869 study showed durable responses with first-line enfortumab vedotin-ejfv plus pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial...
In a phase I study (TROPION-PanTumor01) reported in the Journal of Clinical Oncology, Shimizu et al described outcomes with the trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate datopotamab deruxtecan at the dose selected for further development in patients with advanced...
As reported in the Journal of Clinical Oncology by Caroline Robert, MD, PhD, and colleagues, the 7-year follow-up of the phase III KEYNOTE-006 trial has shown a continued overall survival benefit with pembrolizumab vs ipilimumab in patients with advanced melanoma. The primary analysis of the trial...
In the phase II DESTINY-Gastric02 trial reported in The Lancet Oncology, Eric Van Cutsem, MD, PhD, and colleagues found that fam-trastuzumab deruxtecan-nxki (T-DXd) was active in patients with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a...
New research involving people living with HIV treated with immune checkpoint inhibitors has provided valuable insights into the safety and efficacy of immunotherapy in this historically excluded population, according to data published in the Journal of Clinical Oncology.1 The real-world data...
The formal discussant of the phase II SWOG S1512 trial was Zeynep Eroglu, MD, of the Department of Cutaneous Oncology at the Moffitt Cancer Center in Tampa, Florida. She congratulated Dr. Kendra and her coauthors for conducting a study in such a rare tumor. “I think we can say desmoplastic melanoma ...
The immune checkpoint inhibitor pembrolizumab achieved high response rates in patients with unresectable metastatic desmoplastic melanoma, a rare invasive tumor type, according to the results of the phase II SWOG S1512 trial presented at the 2023 American Association for Cancer Research (AACR)...
In the phase IIIb CheckMate 401 trial reported in the Journal of Clinical Oncology, Reinhard Dummer, MD, and colleagues described outcomes with first-line nivolumab/ipilimumab followed by nivolumab in a clinically diverse population of patients with unresectable stage III or IV melanoma, including...
Shailender Bhatia, MD, of the University of Washington and Fred Hutchinson Cancer Center, discusses phase I/II results on the efficacy of nivolumab with or without ipilimumab in patients with recurrent or metastatic Merkel cell carcinoma. The study found that, for this rare and aggressive skin cancer, nivolumab showed clinical activity in advanced disease. However, these results from CheckMate 358 do not suggest an additional benefit with ipilimumab added to nivolumab (Abstract 9506).
On June 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to glofitamab-gxbm (Columvi) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma,...
Patients with advanced non–small cell lung cancer (NSCLC) may be able to stop receiving immunotherapy at 2 years as long as their cancer hasn’t progressed, according to new findings presented by Sun et al at the 2023 ASCO Annual Meeting (Abstract 9101) and simultaneously published in JAMA Oncology. ...
Patients with early relapsed or refractory large B-cell lymphoma had significantly improved overall survival when treated with the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel when compared to the current standard-of-care chemoimmunotherapy, according to results of the...
Jason J. Luke, MD, of the University of Pittsburgh Medical Center Hillman Cancer Center, discusses adjuvant pembrolizumab, which, in previous results, improved distant metastasis– and recurrence-free survival in patients with resected stage IIB or IIC melanoma vs placebo. After a median follow-up of 39.4 months, adjuvant pembrolizumab continued to show a benefit over placebo, with no new safety signals (Abstract LBA9505).
Jonathan W. Riess, MD, of the University of California, Davis Comprehensive Cancer Center, explores the findings of three important clinical trials in lung cancer treatment: whether to incorporate immune checkpoint inhibitors into the treatment of EGFR-mutated lung cancer, the importance of central nervous system activity in EGFR-mutant lung cancer, and new therapies for disease with EGFR exon 20 insertion.
Narjust Florez, MD, of Dana-Farber Cancer Institute, and Heather A. Wakelee, MD, of Stanford University, Stanford Cancer Institute, discuss new data supporting neoadjuvant pembrolizumab plus chemotherapy followed by surgery and adjuvant pembrolizumab as a promising new treatment option for patients with resectable stage II, IIIA, or IIIB (N2) non–small cell lung cancer (NSCLC) (Abstract LBA100).
Ciltacabtagene autoleucel, a B-cell maturation antigen–targeting chimeric antigen receptor (CAR) T-cell therapy, significantly slows or stops progression of multiple myeloma when compared with standard-of-care treatments among patients with lenalidomide-refractory disease. Results from the...
Allison Betof Warner, MD, PhD, of Stanford University Medical Center, and Adnan Khattak, MBBS, FRACP, PhD, of Australia’s Hollywood Private Hospital & Edith Cowan University, discuss the use of the mRNA-4157 vaccine in combination with pembrolizumab as adjuvant therapy for resected high-risk melanoma, which prolonged distant metastasis–free survival compared with pembrolizumab alone. These results provide further evidence that a personalized neoantigen approach is potentially beneficial (Abstract LBA9503).
Rana R. McKay, MD, of the University of California, San Diego, and Brian I. Rini, MD, of Vanderbilt-Ingram Cancer Center, discuss the 5-year follow-up results with the combination of a checkpoint inhibitor plus a VEGFR tyrosine kinase inhibitor as first-line treatment for patients with advanced clear cell renal cell carcinoma (RCC). Pembrolizumab plus axitinib continued to demonstrate improved survival outcomes as well as overall response rate vs sunitinib for patients with previously untreated disease (Abstract LBA4501).
According to the findings of the international phase II DESTINY-PanTumor02 study presented by Funda Meric-Bernstam, MD, and colleagues at the 2023 ASCO Annual Meeting, fam-trastuzumab deruxtecan-nxki (T-DXd) is an effective treatment option for people with difficult-to-treat, HER2-expressing solid...
Bobbie J. Rimel, MD, of Cedars-Sinai Medical Center, and Isabelle L. Ray-Coquard, MD, PhD, of Centre Léon Bérard and the University Claude Bernard Lyon Est, discuss findings from the COLIBRI trial, which showed that, for patients with cervical squamous cell carcinoma, neoadjuvant nivolumab plus ipilimumab is safe and orchestrates de novo immune responses. The 82.5% complete response rate for primary tumors 6 months after standard chemoradiation therapy suggests favorable clinical outcomes (Abstract 5501).
Georgina V. Long, MD, PhD, of Melanoma Institute Australia and The University of Sydney, discusses new data showing that patients with resected stage IIB/C melanoma who were treated with adjuvant nivolumab had prolonged recurrence-free survival compared with placebo across all biomarker subgroups. The baseline biomarkers most predictive of prolonged recurrence-free survival with nivolumab were high interferon gamma score, high tumor mutational burden, CD8 T-cell infiltration, and low C-reactive protein (Abstract 9504).
Omid Hamid, MD, of The Angeles Clinic & Research Institute, discusses study findings on fianlimab plus cemiplimab-rwlc, which showed clinical activity in patients with advanced melanoma, comparing favorably with other approved combinations of immune checkpoint inhibitors in the same clinical setting. This is the first indication that dual LAG-3 blockade may produce a high level of activity with significant overall response rate after adjuvant anti–PD-1 treatment. A phase III trial of this regimen in treatment-naive patients with advanced melanoma is ongoing (Abstract 9501).
Tycel J. Phillips, MD, and Swetha Kambhampati, MD, both of City of Hope National Medical Center, discuss new findings showing that the real-world effectiveness and safety of brexucabtagene autoleucel were similar to data from the pivotal ZUMA-2 trial in patients with relapsed or refractory mantle cell lymphoma, regardless of prior BTK inhibition, bendamustine, or autologous stem cell transplantation (Abstract 7507).
Bradley J. Monk, MD, of the University of Arizona, Phoenix, and Creighton University, discusses phase III findings from the KEYNOTE-826 study of overall survival results in patients with persistent, recurrent, or metastatic cervical cancer. Study participants received first-line treatment of pembrolizumab plus chemotherapy, with or without bevacizumab, which reduced the risk of death by up to 40% in three different subsets of patients (Abstract 5500).
Shilpa Gupta, MD, of Cleveland Clinic, discusses the results from the EV-103 study and the unmet need for effective first-line therapies in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. After nearly 4 years of follow-up, the trial findings showed that enfortumab vedotin-ejfv plus pembrolizumab continues to demonstrate promising survival trends with rapid and durable responses in this population (Abstract 4505).
The international phase III MIRASOL randomized clinical trial found that mirvetuximab soravtansine-gynx, an antibody and microtubule inhibitor conjugate, significantly improved progression-free and overall survival for patients with platinum-resistant, advanced high-grade epithelial ovarian,...
The immune checkpoint inhibitor nivolumab plus chemotherapy significantly reduced the risk of disease progression and disease-related death compared with standard treatment with the CD30-targeted drug brentuximab vedotin plus chemotherapy in pediatric and adult patients with previously untreated...
The Response Evaluation Criteria in Solid Tumors (RECIST), used in many clinical trials to evaluate changes in tumor burden over time, classify objective tumor response into one of four categories—complete response, partial response, stable disease, or progressive disease—based on the percent of...
In a phase II clinical trial, investigators found that 42% of patients with brain metastases benefited from treatment with the immune checkpoint inhibitor pembrolizumab, with 7 of the 57 patients in the trial surviving for longer than 2 years. The study authors cautioned that these benefits must be ...
Researchers have developed a new strategy to identify which patients with non–muscle-invasive bladder cancer may be most likely to resist first-line treatment with Bacillus Calmette-Guérin (BCG) immunotherapy, according to a new study published by Jong et al in Science Translational Medicine. The...
Adding the PD-1 inhibitor pembrolizumab to chemotherapy, with or without bevacizumab, improved overall survival and progression-free survival in patients with persistent, recurrent, or metastatic cervical cancer, regardless of whether the cancer expressed PD-L1. These findings from the KEYNOTE-826...
The updated results of the POLLUX trial, reported in the Journal of Clinical Oncology by Dimopoulos and colleagues and in this issue of The ASCO Post, showed significantly improved overall survival with daratumumab plus lenalidomide/dexamethasone (DRd) vs Rd in patients with previously treated...
In a meta-analysis reported in a research letter in JAMA Network Open, Maiorano et al found that first-line anti–PD-L1 treatment combinations did not significantly improve overall survival vs sunitinib in patients with metastatic renal cell carcinoma. A progression-free survival benefit was...
Researchers have discovered that interleukin-21 may be a potential therapeutic target to help reduce the endocrine autoimmune adverse effects and prevent the thyroid autoimmunity experienced by patients with cancer undergoing treatment with immune checkpoint inhibitors, according to a novel study...
In a study reported in JAMA Network Open, Charu Aggarwal, MD, MPH, and colleagues found that patients with advanced solid cancers and a high tumor mutational burden (TMB-H) had improved overall survival with immune checkpoint inhibitor therapy vs those with a low tumor mutational burden (TMB-L)....
In the Italian phase II VELO trial reported in JAMA Oncology, Napolitano et al found that anti-EGFR treatment rechallenge with the addition of panitumumab to trifluridine/tipiracil improved progression-free survival in the third-line setting for patients with RAS wild-type metastatic colorectal...
In the phase III GAIA–CLL13 trial reported in The New England Journal of Medicine, Barbara Eichhorst, MD, and colleagues found better outcomes with venetoclax plus obinutuzumab and venetoclax, obinutuzumab, and ibrutinib compared with chemoimmunotherapy as first-line treatment in fit patients with ...
Intratumoral delivery of the engineered oncolytic virus DNX-2401 in combination with subsequent immunotherapy with pembrolizumab may be safe and effective at improving survival outcomes in patients with recurrent glioblastoma, according to a study published by Nassiri et al in Nature Medicine....
Although hypomethylating agents previously appeared to be a promising treatment option for patients with bladder cancer refractory to immunotherapy, researchers were forced to halt a recent phase II clinical trial after patients experienced either no response to treatment or rapid tumor...
New research involving people living with HIV treated with immune checkpoint inhibitors has provided valuable insights into the safety and efficacy of immunotherapy in this historically excluded population, according to data published by El Zarif et al in the Journal of Clinical Oncology. The...
As reported in The New England Journal of Medicine by Prager et al, the phase III SUNLIGHT trial has shown prolonged overall survival with the addition of bevacizumab to trifluridine/tipiracil (FTD-TPI) in previously treated patients with metastatic colorectal cancer. As stated by the...
The targeted kinase inhibitor cabozantinib plus a two-drug immunotherapy combination of nivolumab and ipilimumab may be capable of slowing cancer progression in patients with advanced renal cell carcinoma who received no prior lines of therapy, according to a study published by Choueiri et al in...
Botensilimab (AGEN1181) in combination with balstilimab (AGEN2034) induced durable responses in patients with platinum-resistant or -refractory ovarian cancer, in the ongoing phase Ib C-800 study presented at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer by Bruno...
The sun was out, and the weather was beautiful for the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer held in Tampa, Florida, in March 2023. Participants came from across the world for this second hybrid gathering since the COVID-19 pandemic to share ongoing advances in ...
The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. In this installment, we begin a new series of articles on cancer immunology and immunotherapy, in which the authors discuss how immunotherapy has become a major pillar of...
On April 3, 2023, enfortumab vedotin-ejfv with pembrolizumab was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy.1,2 Enfortumab vedotin-ejfv is an antibody-drug conjugate targeting nectin 4....
As reported in The Lancet Oncology by Xu et al, an interim analysis of the phase III RATIONALE-306 trial has shown improved overall survival with the addition of the anti–PD-1 antibody tislelizumab to chemotherapy in the first-line treatment of advanced or metastatic esophageal squamous cell...