Phase III NALA Trial Meets Primary Endpoint in Previously Treated HER2-Positive Breast Cancer
As reported in the Journal of Clinical Oncology by Cristina Saura, MD, of Vall d’Hebron University Hospital, Barcelona, and colleagues, the phase III NALA trial has shown significantly prolonged progression-free survival with the irreversible pan-HER tyrosine kinase inhibitor neratinib plus...
Newer Therapeutic Approaches Improving Outcomes in Hodgkin Lymphoma
At the 2020 Debates and Didactics in Hematology and Oncology Virtual Conference, sponsored by Emory University School of Medicine and Winship Cancer Institute, Pamela Allen, MD, Assistant Professor of Medicine at Emory, described recent trials on therapeutic approaches that are informative on this...
Meta-analyses of Quality of Life in Patients Treated With Checkpoint Inhibitors
Findings from two meta-analyses designed to summarize quality-of-life data on patients receiving immune checkpoint inhibitor therapy for cancer were presented at the ESMO Virtual Congress 2020 (Abstract 1568O). These meta-analyses found that patients receiving immune checkpoint inhibitors had...
Nivolumab Shows Activity in edPOLE-Mutated, MMR-Proficient Advanced Cancers
Nivolumab monotherapy showed high response and disease control rates in patients with pathogenic exonuclease domain POLE (edPOLE)-mutated, mismatch repair (MMR)-proficient advanced tumors containing confirmed pathogenic mutations, according to findings presented by Benoit J.C. Rousseau, MD, PhD, of ...
Continuous vs Fixed-Duration Immunotherapy in Previously Treated Patients With Advanced NSCLC
In an exploratory analysis of the phase IIIb/IV CheckMate 153 trial published in the Journal of Clinical Oncology, David M. Waterhouse, MD, MPH, and colleagues found that continuing nivolumab beyond 1 year of treatment vs stopping at 1 year of treatment was associated with better outcomes in...
Adjuvant Nivolumab vs Ipilimumab in Resected Advanced Melanoma: Long-Term Follow-up of CheckMate 238
Long-term findings from the phase III CheckMate 238 study showed that nivolumab improved 4-year recurrence-free survival compared with ipilimumab in patients with resected stage IIIB to C or IV melanoma in the overall population as well as across subgroups of patients stratified by disease stage...
Association of Tumor Mutational Burden With Response to Pembrolizumab in Previously Treated Patients With Advanced Solid Tumors
A prospective biomarker analysis of the multicohort phase II KEYNOTE-158 trial reported by Marabelle et al in The Lancet Oncology found that patients with previously treated advanced solid tumors were more likely to respond to pembrolizumab monotherapy if they had high tissue tumor mutational...
Early-Phase Trial Explores Cabozantinib and Nivolumab With or Without Ipilimumab in Advanced Genitourinary Malignancies
In a phase I trial reported in the Journal of Clinical Oncology, Andrea B. Apolo, MD, and colleagues found that the combination of cabozantinib and nivolumab, as well as the combination of cabozantinib/nivolumab plus ipilimumab, produced durable responses in patients with metastatic urothelial...
Benjamin Besse, MD, PhD, on NSCLC: Neoadjuvant Atezolizumab for Resectable Disease
Benjamin Besse, MD, PhD, of the Gustave Roussy Cancer Centre, discusses results of the phase II PRINCEPS trial, which assessed, for the first time, the effect of just one injection of the immunotherapy atezolizumab before surgery in patients with resectable non–small cell lung cancer (Abstract 1215O).
Paolo A. Ascierto, MD, on Melanoma: Sequencing Targeted Treatments and Immunotherapy
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori, discusses phase II results on progression-free survival for patients with advanced melanoma in the SECOMBIT study, whose aim is to evaluate the different sequencing of a BRAF inhibitor (encorafenib) plus a MEK inhibitor (binimetinib) with ipilimumab plus nivolumab (Abstract LBA45).
Thierry Andre, MD, on Colorectal Cancer: Health-Related Quality of Life With Pembrolizumab vs Chemotherapy
Thierry Andre, MD, of Hôpital Saint-Antoine, discusses phase III KEYNOTE-177 findings on the reduced risk of disease progression or death in patients receiving pembrolizumab monotherapy as a first-line treatment of microsatellite instability–high and/or mismatch repair–deficient metastatic colorectal cancer (Abstract 396O).
Sumanta K. Pal, MD, on Renal Cell Carcinoma: Cabozantinib Plus Atezolizumab as First-Line Therapy
Sumanta K. Pal, MD, of the City of Hope National Medical Center, discusses results from the COSMIC-021 study, which tested two different doses of cabozantinib, each with a standard dose of atezolizumab, administered to patients with metastatic advanced clear cell renal cell carcinoma. Dr. Pal reports on response rates and progression-free survival, as well as biologic correlates that may have influenced response (Abstract 702O).
First-Line Checkpoint Inhibitors May Improve Survival in Gastroesophageal Cancers
Immune therapy for advanced gastroesophageal cancer has taken a leap forward by showing its value in the first-line setting, according to two studies in which nivolumab and pembrolizumab, both given with chemotherapy, significantly improved overall survival vs chemotherapy alone. The studies,...
Ezra E.W. Cohen, MD, on Head and Neck Cancer: Avelumab and Chemoradiotherapy in Locally Advanced Disease
Ezra E.W. Cohen, MD, of the University of California, San Diego, discusses primary results of the phase III JAVELIN trial of locally advanced squamous cell carcinoma of the head and neck, in which the immune checkpoint inhibitor avelumab was combined with chemoradiotherapy followed by avelumab maintenance. Although the study results were negative, Dr. Cohen suggests other regimens that may prove to be effective (Abstract 910O).
Toni K. Choueiri, MD, on RCC: Nivolumab Plus Cabozantinib vs Sunitinib in First-Line Treatment
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses the first results from the phase III CheckMate 9ER trial, which suggested the combination of nivolumab and cabozantinib is safe. It showed activity in progression-free and overall survival, as well as in overall response rates and may have a place in treating patients with metastatic renal cell carcinoma (Abstract 696O_PR).
CheckMate 9ER Trial Shows Benefit of Novel Doublet for Advanced Kidney Cancer
The combination of nivolumab plus cabozantinib was superior to the former standard, sunitinib, as first-line treatment for advanced/metastatic renal cell carcinoma, according to results of the phase III CheckMate 9ER trial reported by Toni K. Choueiri, MD, and colleagues at the ESMO Virtual...
Maintenance Avelumab Plus Best Supportive Care in Advanced Bladder Cancer
Findings from the JAVELIN Bladder 100 trial were published by Thomas Powles, MD, and colleagues in The New England Journal of Medicine. Researchers reported that the PD-L1 inhibitor avelumab led to a 31% reduction in risk of death, and extended median survival by more than 7 months in patients with ...
Addition of Pembrolizumab to Eribulin in HR-Positive, HER2-Negative Metastatic Breast Cancer
In a phase II trial reported in JAMA Oncology, Sara M. Tolaney, MD, MPH, and colleagues found that the addition of pembrolizumab to eribulin did not improve progression-free survival in women with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer. As stated by the...
First-Line PD-1 Inhibitor With or Without Chemotherapy vs Chemotherapy Alone in Advanced Gastric Cancer: KEYNOTE-062
As reported in JAMA Oncology by Kohei Shitara, MD, and colleagues, the phase III KEYNOTE-062 trial showed no significant improvement in overall or progression-free survival with first-line pembrolizumab with or without chemotherapy vs chemotherapy alone in patients with PD-L1–positive advanced...
Proton Pump Inhibitor Use May Be Associated With Worse Outcomes in Patients Treated With Atezolizumab for Urothelial Cancer
Recent evidence indicates that proton pump inhibitors may cause significant changes in the gut microbiota; gut microbiota dysbiosis has been linked to reduced immune checkpoint inhibitor effectiveness. In a retrospective analysis of clinical trials investigating the immune checkpoint inhibitor...
Meta-analysis of Duration of Adjuvant Trastuzumab in Early Breast Cancer
In individual participant data and trial-level meta-analyses reported in JAMA Network Open, Gulia et al found that disease-free survival with adjuvant trastuzumab given for less than 1 year was noninferior to 1 year of trastuzumab therapy in patients with early breast cancer. In addition, the...
Dr. Kantarjian Shares His Thoughts on Optimizing the Treatment of Adults With ALL
In the treatment of adults with acute lymphoblastic leukemia (ALL), use of newer antibodies and de-intensification of chemotherapy have greatly improved outcomes, according to Hagop Kantarjian, MD, who has been very involved in much of the research in ALL treatment. Dr. Kantarjian, Professor and...
Combination Immunotherapy Benefits Subset of Patients With Advanced Prostate Cancer
Results from a phase II trial led by researchers at The University of Texas MD Anderson Cancer Center suggest that a combination of ipilimumab (anti–CTLA-4) plus nivolumab (anti–PD-1) can generate durable responses in a subset of patients with metastatic castration-resistant prostate cancer, an...
Immune Checkpoint Inhibitor Therapy May Contribute to Arterial Inflammation
According to findings from a small study published by Calabretta et al in Circulation, treatment with immune checkpoint inhibitors may worsen inflammation in the arteries that distribute blood from the heart. The research found increased inflammation in the large arteries of 20 Austrian patients...
First-Line Durvalumab Plus Cisplatin/Pemetrexed in Malignant Pleural Mesothelioma
As reported in The Lancet Oncology by Nowak et al, the Australian phase II DREAM trial showed activity with the triplet of durvalumab plus cisplatin/pemetrexed in previously untreated patients with advanced malignant mesothelioma. Study Details In the multicenter trial, 54 evaluable patients with...
Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphomas
In the TRANSCEND NHL 001 study reported in The Lancet, Jeremy S. Abramson, MD, and colleagues found that the autologous CD19-directed chimeric antigen receptor (CAR) T-cell agent lisocabtagene maraleucel (liso-cel) produced a high response rate in patients with relapsed or refractory large B-cell...
Atezolizumab Plus Cobimetinib/Vemurafenib in BRAF V600–Positive Unresectable or Metastatic Melanoma
On July 30, 2020, atezolizumab was granted approval for use in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation–positive unresectable or metastatic melanoma.1,2 Supporting Efficacy Data Approval was based on findings from the phase III, double-blind IMspire150 trial ...
Avelumab in Maintenance Treatment of Urothelial Carcinoma
On June 30, 2020, avelumab was approved for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings in the randomized, multicenter, ...
Update on Novel Immunotherapies for Plasma Cell Disorders
In this installment of The ASCO Post’s Hematology Expert Review, we take a closer look at the monoclonal antibody targeting CD38, daratumumab, in the treatment of amyloid light chain (AL) amyloidosis and resistant multiple myeloma as well as the antibody-drug conjugate belantamab mafodotin-blmf,...
Growing Body of Evidence Supports Adjuvant Immunotherapy for Stage IV Melanoma With No Evidence of Disease
With incredibly paced approvals and clinical advancements in the systemic therapy of cutaneous melanoma, the efficacy of immunotherapy in this disease is clear. However, many important questions remain regarding timing and dosing—in other words, which drug (or drugs) makes the most sense and in...
Expert Point of View: Dean A. Fennell, FRCP, PhD
Invited discussant of the CheckMate 743 trial, Dean A. Fennell, FRCP, PhD, Director of the Mesothelioma Research Program and Chair of Thoracic Oncology at The University of Leicester and University Hospitals of Leicester, United Kingdom, noted the combination of nivolumab and ipilimumab has been...
Nivolumab Plus Ipilimumab: New Standard of Care in First-Line Treatment of Unresectable Malignant Pleural Mesothelioma?
Immunotherapy is taking on yet another highly aggressive cancer and yielding strong results, according to data presented during the 2020 International Association for the Study of Lung Cancer’s World Conference on Lung Cancer Virtual Presidential Symposium.1 A prespecified interim analysis of the...
New Study Focuses on Multiorgan Immunotherapy-Related Adverse Events in Clinical Trials
A new study published by Kichenadasse et al in JNCCN—Journal of the National Comprehensive Cancer Network concentrates on how immunotherapy-related adverse events may impact more than one organ in a single patient. This study provides new information on how frequently multiorgan side effects occur...
FDA Issues Alert About Efficacy and Potential Safety Concerns Regarding Atezolizumab Plus Paclitaxel in Metastatic Triple-Negative Breast Cancer
On September 8, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated, inoperable, locally advanced or metastatic...
CLL14 Trial Follow-up: Venetoclax Plus Obinutuzumab in Previously Untreated Patients With Chronic Lymphocytic Leukemia
As reported in The Lancet Oncology by Al-Sawaf et al, 3-year follow-up of the phase III CLL14 trial showed maintained significant improvement in progression-free survival with the fixed-duration regimen of venetoclax/obinutuzumab vs chlorambucil/obinutuzumab in previously untreated patients with...
Expert Point of View: TROPHIMMUN Trial
Two gynecologic oncologists and ASCO’s Chief Medical Officer and Executive Vice President Richard L. Schilsky, MD, FACP, FSCT, FASCO, commented on the findings of the TROPHIMMUN trial for The ASCO Post. “The authors demonstrate efficacy of a new treatment approach for gestational trophoblastic...
TROPHIMMUN Trial Finds Avelumab Effective in Rare Gynecologic Tumor Resistant to Chemotherapy
The first trial of immunotherapy for gestational trophoblastic tumors proved effective in almost 50% of patients resistant to single-agent chemotherapy, French investigators reported in an abstract presented during the ASCO20 Virtual Scientific Program.1 The results of the phase II TROPHIMMUN trial ...
Lenvatinib/Pembrolizumab in Previously Treated Patients With Advanced Endometrial Cancer
As reported in the Journal of Clinical Oncology by Vicky Makker, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, findings from a phase Ib/II trial indicate that the combination of lenvatinib and pembrolizumab is active in patients with previously treated advanced...
Addition of Trastuzumab to Carboplatin/Paclitaxel for Advanced or Recurrent HER2-Positive Uterine Serous Carcinoma
Combining the HER2-targeted therapy trastuzumab with carboplatin and paclitaxel improved survival rates for women with a rare, aggressive type of endometrial cancer, according to findings published by Amanda N. Fader, MD, of Johns Hopkins School of Medicine, Baltimore, and colleagues in Clinical...
Expert Point of View: Nicoletta Colombo, MD
The invited discussant of the two trials in cervical and endometrial cancers presented at the ESMO Congress 2019 was Nicoletta Colombo, MD, of the University of Milan-Bicocca in Italy, who commented on what she called “exciting results in cancers with unmet needs.” Dr. Colombo noted: “The studies...
ESMO 2019: Immunotherapy in Cervical and Endometrial Cancers
In studies reported at the ESMO Congress 2019, immunotherapy yielded encouraging outcomes in two gynecologic cancer populations in need of new treatments, including patients with advanced cervical cancer that is microsatellite-stable and patients previously treated for advanced endometrial cancer....
KEYNOTE-100: In Women With Advanced Ovarian Cancer, Pembrolizumab Yields Modest Antitumor Efficacy
the final results of the phase II KEYNOTE-100 study of pembrolizumab in women with advanced and recurrent ovarian cancer showed that pembrolizumab monotherapy produced modest clinical activity. Ursula Matulonis, MD, of Dana-Farber Cancer Institute, Harvard Medical School, reported the data at the...
Adjuvant Nivolumab Plus Ipilimumab vs Nivolumab Alone in Resected Stage IV Melanoma With No Evidence of Disease
In an interim analysis of the German phase II IMMUNED trial reported in The Lancet, Lisa Zimmer, MD, of University Hospital Essen, and colleagues found that adjuvant nivolumab plus ipilimumab and nivolumab alone significantly prolonged recurrence-free survival vs placebo in patients with resected...
Is It Time to Add Checkpoint Inhibitors to the Treatment of Locally Advanced Lung Cancer?
After more than 20 years of failed strategies to improve survival rates for locally advanced lung cancers, checkpoint inhibitors have revolutionized therapy, but prognoses still lag behind other tumor types. During the ASCO20 Virtual Education Program, Mark G. Kris, MD, FASCO, a thoracic medical...
Assessment of Potential Abscopal Effect of SBRT Added to Nivolumab in Metastatic Head and Neck Cancer
In a single-center phase II trial reported in the Journal of Clinical Oncology, McBride et al found that use of stereotactic body radiotherapy (SBRT) for a potential abscopal effect together with nivolumab did not improve objective response rate vs nivolumab alone in patients with metastatic head...
Meta-analysis of FOLFOXIRI/Bevacizumab vs Doublets/Bevacizumab as Initial Treatment for Unresectable Metastatic Colorectal Cancer
In a patient-level meta-analysis reported in the Journal of Clinical Oncology, Chiara Cremolini, MD, PhD, and colleagues found that infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus bevacizumab was associated with significantly greater overall survival vs...
ORIENT-11 Trial Shows Sintilimab Plus Chemotherapy Improves Progression-Free Survival in Advanced NSCLC
The first-line setting for patients with locally advanced or metastatic non-squamous non–small cell lung cancer (NSCLC) now has become more complicated, according to data presented during the 2020 International Association for the Study of Lung Cancer’s World Conference on Lung Cancer Virtual...
The Parker Institute for Cancer Immunotherapy Appoints John Connolly, PhD, as Chief Scientific Officer
The Parker Institute for Cancer Immunotherapy (PICI) announced that John Connolly, PhD, has been named Chief Scientific Officer. In this role, Dr. Connolly will design and execute PICI’s overall research strategy in close collaboration with the institute’s leadership team, center directors, and...
Researchers Outline Need for Evaluation of Gene-Expression Profiling in Melanoma
A consensus statement published in JAMA Dermatology by an international group of melanoma researchers evaluated the use of prognostic gene-expression profile testing to guide clinical management of melanoma.1 The group cautioned against the routine use of currently available gene-expression...
Tafasitamab-cxix in the Treatment of Diffuse Large B-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 31, 2020, tafasitamab-cxix, a CD19-directed...
