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In a National Institutes of Health study reported in the Journal of Clinical Oncology, Zacharakis et al found that treatment with autologous tumor-infiltrating lymphocytes (TILs) reactive to mutations in metastatic lesions produced responses in patients with metastatic breast cancer. Study Details...
Thierry André, MD, of Sorbonne University and Saint-Antoine Hospital, discusses phase II results from the GERCOR NEONIPIGA study, which suggests neoadjuvant therapy with nivolumab and ipilimumab may be associated with a high pathologic complete response rate in patients with localized microsatellite instability–high or mismatch repair–deficient esophagogastric adenocarcinoma. This study raises the question of whether surgery could be delayed or avoided for some patients (Abstract 244).
Romain Cohen, MD, PhD, of Sorbonne University and Saint-Antoine Hospital, discusses phase II results of the GERCOR NIPICOL study, which suggests nivolumab plus ipilimumab at a fixed duration of 1 year continued to show durable activity in patients with chemoresistant microsatellite instability–high/mismatch repair–deficient metastatic colorectal cancer after 3 years of follow-up. Dr. Cohen points out there is now some question as to whether all patients need 2 years of therapy (Abstract 13).
In the Chinese phase III GEMSTONE-302 trial reported in The Lancet Oncology, Caicun Zhou, MD, and colleagues found that the addition of the PD-L1 inhibitor sugemalimab to platinum-based chemotherapy improved progression-free survival in the first-line treatment of metastatic squamous or nonsquamous ...
Melissa Amy Lumish, MD, of Memorial Sloan Kettering Cancer Center, discusses new findings showing a 100% complete response rate to PD-1 blockade alone among the first 11 patients with locally advanced mismatch repair–deficient rectal cancer treated with this approach. None of the patients required chemoradiation or surgery, thus avoiding their attendant morbidities, and so PD-1 blockade may represent a new treatment paradigm. Follow-up on the durability of response is needed (Abstract 16).
Van K. Morris, MD, of The University of Texas MD Anderson Cancer Center, discusses phase I/II data suggesting that encorafenib plus cetuximab and nivolumab is safe and well tolerated for patients with microsatellite-stable BRAF V600E–mutated metastatic colorectal cancer (Abstract 12).
On January 31, the FDA approved an update to the prescribing information for axicabtagene ciloleucel (Yescarta) to include use of prophylactic corticosteroids across all approved indications. Axicabtagene ciloleucel is now the first and only chimeric antigen receptor (CAR) T-cell therapy with...
In a French phase II trial (IFCT-1703-R2D2) reported in the Journal of Clinical Oncology, Julien Mazieres, MD, PhD, and colleagues found that the combination of trastuzumab, pertuzumab, and docetaxel produced durable responses in previously treated patients with advanced HER2-mutant non–small cell...
In a phase II trial reported in The Lancet Oncology, Jonathan Schoenfeld, MD, and colleagues found that the addition of low-dose or hypofractionated radiotherapy to durvalumab plus tremelimumab did not improve objective response rates in patients with metastatic non–small cell lung cancer (NSCLC)...
Zev A. Wainberg, MD, of the University of California, Los Angeles, discusses an update, of 25 additional months, on phase III safety and efficacy results from the KEYNOTE-062 trial. This study compared pembrolizumab with or without chemotherapy vs chemotherapy alone for patients with PD-L1–positive advanced gastric or gastroesophageal junction adenocarcinoma (Abstract 243).
As reported in the Journal of Oncology by Reinhard Dummer, MD, and colleagues, the phase III COMBI-i trial has shown no significant progression-free survival benefit with the addition of the anti–PD-1 antibody spartalizumab to dabrafenib and trametinib in patients with no prior systemic treatment...
As reported in The Lancet Oncology by Howard P. Safran, MD, and colleagues, the phase III NRG Oncology/RTOG-101 trial has shown no significant disease-free survival benefit with the addition of perioperative trastuzumab to neoadjuvant chemoradiation in previously untreated patients with...
As reported in The New England Journal of Medicine by Vicky Makker, MD, and colleagues, the phase III Study 309-KEYNOTE-775 trial has shown prolonged progression-free and overall survival with lenvatinib plus pembrolizumab vs physician’s choice of chemotherapy among previously treated patients with ...
Afsaneh Barzi, MD, PhD, of City of Hope Comprehensive Cancer Center and AccessHope, discusses results from a phase I/II study of regorafenib and pembrolizumab in refractory microsatellite-stable colorectal cancer. Although the trial did not meet its primary endpoint, the median overall survival is “provocative,” says Dr. Barzi. An analysis of biomarkers to identify patients with a longer duration of benefit is ongoing (Abstract 15).
Ghassan K. Abou-Alfa, MD, MBA, of Memorial Sloan Kettering Cancer Center and Weill Medical College at Cornell University, discusses phase III results of the HIMALAYA trial, which showed the combination of a single priming dose of tremelimumab added to durvalumab is superior to sorafenib for patients with unresectable hepatocellular carcinoma (Abstract 379).
Nilofer Saba Azad, MD, of Johns Hopkins Sidney Kimmel Cancer Center, assesses the findings from the phase III TOPAZ-1 trial, a study of durvalumab in combination with gemcitabine plus cisplatin in patients with advanced biliary tract cancer. Dr. Azad explains why the study sets a potential new standard of care of gemcitabine plus cisplatin and durvalumab in unselected patients.
On December 3, 2021, pembrolizumab was approved for adjuvant treatment of adult and pediatric (≥ 12 years of age) patients with stage IIB or IIC melanoma following complete resection.1 Supporting Efficacy Data Approval was based on findings in the phase III, double-blind KEYNOTE-716 trial...
On November 30, 2021, daratumumab/hyaluronidase-fihj and carfilzomib were approved for use in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who had one to three prior lines of therapy.1,2 Supporting Efficacy Data Approval was based on findings in a cohort...
On December 2, 2021, rituximab was approved for use in combination with chemotherapy for pediatric patients (≥ 6 months to 18 years) with previously untreated, advanced-stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.1...
Adjuvant platinum-based chemotherapy for early-stage non–small cell lung cancer (NSCLC) is currently almost an afterthought and is taken for granted as a standard of care for patients with stage II to IIIA NSCLC after resection. The earliest meta-analysis, published in 1995,1 gave the first hint of ...
As reported in The Lancet by Enriqueta Felip, MD, of Vall d’Hebron University Hospital, Barcelona, and colleagues, the phase III IMpower010 trial has shown improved disease-free survival with adjuvant atezolizumab vs best supportive care in the predefined population of patients with resected stage ...
A greater understanding of the mutational landscape in non–small cell lung cancer (NSCLC) has identified key oncogenes, such as EGFR, ALK, ROS, RET, and BRAF, among others. These discoveries, coupled with the availability of specific targeted small-molecule inhibitors, have transformed the...
Multiple comparisons of traditional cytotoxic chemotherapy combinations that began decades ago led to the adoption of the platinum plus fluorouracil doublet as the standard of care for treatment of recurrent or metastatic esophageal cancer.1 Other combinations created by the addition and/or...
The autologous chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel failed to improve event-free survival vs standard-of-care treatment strategies in patients with aggressive, relapsed or refractory non-Hodgkin lymphoma (NHL), according to results of the phase III BELINDA trial,...
After almost a century of limited efficacy of cancer immunotherapy,1 the breakthrough happened in 2012 with the discovery of immune checkpoint inhibitors,2,3 leading to the 2018 Nobel Prize in Physiology or Medicine for James P. Allison and Tasuku Honjo. Yet about 40% of patients on immune...
In a single-institution study reported in The Lancet Oncology, David C. Qian, MD, PhD, and Zachary S. Buchwald, MD, PhD, of Winship Cancer Institute of Emory University, Atlanta, and colleagues found that patients with metastatic melanoma who received at least 20% of immune checkpoint inhibitor...
Heinz-Josef Lenz, MD, of USC Norris Comprehensive Cancer Center, discusses phase II results from the CheckMate 9X8 study, which compared nivolumab plus fluorouracil/leucovorin/oxaliplatin (mFOLFOX6) and bevacizumab vs mFOLFOX6 and bevacizumab in the first-line treatment of metastatic colorectal cancer. A subgroup of patients may benefit from adding nivolumab to the standard of care in this setting (Abstract 8).
In the phase II DESTINY-Lung01 trial reported in The New England Journal of Medicine, Bob T. Li, MD, PhD, MPH, and colleagues found that fam-trastuzumab deruxtecan-nxki (T-DXd) showed durable activity in patients with metastatic HER2-mutant non–small cell lung cancer (NSCLC) refractory to standard...
In an analysis from the phase II CALGB 40603/Alliance trial reported in the Journal of Clinical Oncology, Shepherd et al found that the addition of carboplatin or bevacizumab to neoadjuvant chemotherapy was not associated with improved long-term outcomes in patients with stage II or III...
As reported in the Journal of Clinical Oncology by David M. O’Malley, MD, and colleagues, pembrolizumab showed durable activity in a cohort of patients with microsatellite instability–high or mismatch repair–deficient (MSI-H/dMMR) advanced endometrial cancer enrolled in the multicohort KEYNOTE-158...
Kohei Shitara, MD, of Japan’s National Cancer Center Hospital East, discusses a long-term data follow-up from CheckMate 649, which support the continued use of nivolumab plus chemotherapy as first-line treatment in patients with advanced gastric, gastroesophageal junction, and esophageal adenocarcinomas (Abstract 240).
Independent drug action—not synergy nor additivity—accounted for the clinical efficacy of nearly all examined combination therapies involving immune checkpoint inhibitors in clinical trials, according to results from a retrospective analysis published by Palmer et al in Clinical Cancer Research....
Results from the randomized international phase III HIMALAYA trial showed that a combination of the anti–PD-L1 immunotherapy durvalumab plus the anti–CTLA-4 immunotherapy tremelimumab reduced the risk of death by 22% in patients with stage III or IV unresectable hepatocellular carcinoma compared to ...
In an Asian phase II/III trial (ATTRACTION-4) reported in The Lancet Oncology, Yoon-Koo Kang, MD, and colleagues found that the addition of nivolumab to oxaliplatin-based chemotherapy improved progression-free survival—but not overall survival—as first-line treatment of HER2-negative, unresectable, ...
Yevgeniy R. Semenov, MD, of Massachusetts General Hospital and Harvard Medical School, discusses new findings suggesting cutaneous adverse events such as vitiligo, lichenoid dermatitis, and psoriasis—which often occur in patients with cancer who receive immune checkpoint inhibitors—may be strongly associated with response to therapy and a 22% reduction in mortality (Abstract 814).
Biliary tract cancer is a rare and often fatal disease comprised primarily of bile duct and gallbladder cancers; it is diagnosed in about 12,000 individuals each year in the United States. The cancer has a 5-year relative survival rate of 25% for localized intrahepatic bile duct cancers and just...
In a recent phase II clinical trial, the combination of the PD-L1 inhibitor durvalumab and the CTLA-4 inhibitor tremelimumab curtailed tumor growth in some patients with non–small cell lung cancer (NSCLC) that was resistant to a single immunotherapy agent. The addition of radiation therapy to the...
In an analysis from the phase III CheckMate 9ER trial reported in The Lancet Oncology, David Cella, PhD, FASCO, and colleagues found that nivolumab/cabozantinib was associated with maintained or improved patient-reported outcomes vs sunitinib in the first-line treatment of advanced renal cell...
Mehmet Altan, MD, of The University of Texas MD Anderson Cancer Center, discusses findings from a phase Ib dose-escalation study, which showed early evidence of activity for NKTR-255, an investigational IL-15 receptor agonist, plus cetuximab in patients with solid tumors. Treatment appeared to lead to expansion and proliferation of NK and CD8+ cells (Abstract 957).
Immune checkpoint inhibitors have become the standard of care for many patients with advanced cancers; however, these medications cause cutaneous adverse events in 20% to 40% of all patients who receive them. A study by Tang et al published in JAMA Dermatology indicated that these side effects may...
Elizabeth A. Mittendorf, MD, PhD, of Dana-Farber Brigham and Women’s Cancer Center, discusses the progress made in recent years treating patients with triple-negative breast cancer (TNBC), including approval of the immunotherapy agents pembrolizumab and sacituzumab govitecan-hziy, a new standard of care in the preoperative setting for early-stage disease, as well as a better understanding of the biology of TNBC and its heterogeneity.
As reported in JAMA Oncology by Robert J. Motzer, MD, and colleagues, the final overall survival analysis of the phase III IMmotion151 trial has shown no significant difference for atezolizumab plus bevacizumab vs sunitinib in previously untreated patients with metastatic renal cell carcinoma...
Romanos Sklavenitis-Pistofidis, MD, of Dana-Farber Cancer Institute, discusses study findings on a next generation of clinical assays to assess both tumor biology and immune state, as well as common clinical biomarkers in the marrow or blood. These biomarkers may accurately predict which patients with smoldering multiple myeloma might benefit from early treatment, monitor response to immunotherapy, and improve patient outcomes (Abstract 330).
Manali Kamdar, MD, of the University of Colorado Cancer Center, discusses phase III results from the TRANSFORM study, which suggest that lisocabtagene maraleucel, a CD19-directed CAR T-cell therapy, improved outcomes with a favorable safety profile and may be a potential new standard of care for second-line treatment of patients with relapsed or refractory large B-cell lymphoma (Abstract 91).
In a pooled analysis of individual patient data from trials in the U.S. Food and Drug Administration database reported in JAMA Oncology, Anscher et al found that patients with cancer receiving radiotherapy within 90 days prior to the start of immune checkpoint inhibitor treatment were not at...
In the phase II/III RELATIVITY-047 trial reported in The New England Journal of Medicine, Hussein A. Tawbi, MD, PhD, and colleagues found that the addition of relatlimab, a lymphocyte-activation gene 3 (LAG-3)-blocking antibody, to nivolumab, a PD-1 inhibitor, significantly prolonged...
In a phase I study reported in the Journal of Clinical Oncology, L. Elizabeth Budde, MD, PhD, and colleagues found that the CD20-CD3 bispecific antibody mosunetuzumab produced durable responses in patients with relapsed or refractory aggressive and indolent B-cell non-Hodgkin lymphomas....
In the phase II ADAPT-IT trial reported in the Journal of Clinical Oncology, Michael A. Postow, MD, and colleagues showed that findings on interim computed tomography (CT) allowed patients to avoid the third and fourth doses of combination nivolumab/ipilimumab for the treatment of advanced...
In an analysis from the Pediatric Real-World Chimeric Antigen Receptor Consortium reported in the Journal of Clinical Oncology, Schultz et al found that pretreatment high disease burden was associated with poorer outcomes in pediatric and young adult patients who received commercial...
Patrick Hwu, MD, of Moffitt Cancer Center and President of the Society for Immunotherapy of Cancer (SITC), and Mary Dean, JD, CAE, SITC Executive Director, discuss the organization’s mission, strides made in cancer immunology, meeting the challenge of immunoresistance, and the new SITC app for clinical practice guidelines. This app places a useful tool in the hands of health-care providers, one that can be continually updated as the science evolves.