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Mansoor R. Mirza, MD, on Ovarian Cancer: Roundup of ESMO 2019 Top Abstracts
Mansoor R. Mirza, MD, of Copenhagen University Hospital, offers his perspective on three studies presented in the Presidential Symposium: the PRIMA/ENGOT-OV26/ GOG-3012 trial (niraparib for newly diagnosed advanced disease); the PAOLA-1/ENGOT-ov25 trial (olaparib plus bevacizumab maintenance...
Ana Maria Arance Fernandez, MD, PhD, on Advanced Melanoma: Treatment With Cobimetinib/Atezolizumab vs Pembrolizumab
Ana Maria Arance Fernandez, MD, PhD, of the Hospital Clínic de Barcelona, discusses the negative results of the phase III IMspire170 trial, which evaluated cobimetinib/atezolizumab vs pembrolizumab monotherapy in patients with BRAF V600 wild-type melanoma (Abstract LBA69).
Georgina V. Long, MD, PhD, on Melanoma Brain Metastases: Nivolumab Alone or Nivolumab/Ipilimumab
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, The University of Sydney, discusses long-term outcomes from a phase II trial which showed that nivolumab/ipilimumab therapy demonstrated durable intracranial responses in patients with melanoma brain metastases. No new adverse events...
Solange Peters, MD, PhD, on NSCLC: CheckMate 227 Trial of Nivolumab/Ipilimumab vs Chemotherapy
Solange Peters, MD, PhD, of the Oncology Department of CHUV, discusses study findings from the first phase III trial to show PD-1 and CTLA-4 inhibition is effective in non–small cell lung cancer, with improved overall survival vs chemotherapy (Abstract LBA4).
Sungjune Kim, MD, PhD, on Merkel Cell Carcinoma: Nivolumab/Ipilimumab Plus SBRT
Sungjune Kim, MD, PhD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses phase II study findings on the safety and tolerability of nivolumab/ipilimumab plus stereotactic body radiation therapy (Abstract 1321P).
Sherene Loi, MD, PhD, and Leisha A. Emens, MD, PhD, on HER2-Positive Breast Cancer: KATE2 Study of Atezolizumab/Trastuzumab Emtansine
Sherene Loi, MD, PhD, of Peter MacCallum Cancer Centre at the University of Melbourne, and Leisha A. Emens, MD, PhD, of UPMC Hillman Cancer Center, discuss overall survival in this phase II study of atezolizumab/trastuzumab emtansine (T-DM1) vs placebo/T-DM1 in previously treated HER2-positive...
Peter Schmid, MD, PhD, on Triple-Negative Breast Cancer: KEYNOTE-522 Trial of Pembrolizumab Plus Chemotherapy
Peter Schmid, MD, PhD, of Queen Mary University of London Barts Cancer Institute, discusses pathologic complete response data from a phase III study of pembrolizumab/chemotherapy vs placebo/chemotherapy as neoadjuvant treatment, followed by pembrolizumab vs placebo as 6-month adjuvant treatment for ...
Isabelle Ray-Coquard, MD, PhD, on Ovarian Cancer: Olaparib Plus Bevacizumab
Isabelle Laure Ray-Coquard, MD, PhD, of the Centre Leon Bérard, discusses phase III study findings in patients with newly diagnosed, advanced ovarian cancer who received olaparib plus first-line bevacizumab maintenance treatment. Compared with placebo plus bevacizumab, olaparib improved...
Thomas Powles, MD, PhD, on Metastatic Urothelial Cancer: Durvalumab Plus Targeted Treatments
Thomas Powles, MD, PhD, of Queen Mary University of London, discusses the first study to examine immunotherapy and targeted treatment combinations with a personalized approach in bladder cancer. FGF, TORC1/2, and PARP inhibitors were explored in combination with durvalumab in selected patients...
Paolo A. Ascierto, MD, on Melanoma: Results From CheckMate 238 on Adjuvant Nivolumab vs Ipilimumab
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori, Napoli, discusses phase III study findings confirming the superior activity of nivolumab vs ipilimumab in resected stage III/IV melanoma in terms of regression-free survival after a minimum follow-up of 36 months (Abstract 1310O).
Michael J. LaRiviere, MD, on Non-Hodgkin Lymphoma: Induction Radiation Before CAR T-Cell Therapy for Resistant Disease
Michael J. LaRiviere, MD, of the University of Pennsylvania, discusses the safety and efficacy of an alternate radiation-based approach to using cytotoxic chemotherapy alone in preparation for CAR T-cell treatment (Abstract 135).
Andreas Rimner, MD, on the PACIFIC Trial: Durvalumab for Stage III NSCLC
Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, discusses study findings showing that, for patients with stage III non–small cell lung cancer, durvalumab reduced the rate of and time to disease progression vs placebo and also reduced the number of new distant lesions (Abstract LBA6).
Nivolumab/Brentuximab Vedotin in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma
As reported in the Journal of Clinical Oncology by Zinzani et al, findings in a phase II expansion cohort of the CheckMate 436 study indicated high levels of activity with the combination of nivolumab and brentuximab vedotin in relapsed or refractory primary mediastinal large B-cell lymphoma. As...
T-Cell Receptor Gene Therapy in HPV-Associated Epithelial Cancers
In a first-in-human phase I/II study reported in the Journal of Clinical Oncology, Doran et al found that autologous genetically engineered T cells expressing a T-cell receptor directed against the human papillomavirus (HPV)16 E6 oncoprotein were capable of inducing tumor regression in metastatic,...
Pooled Analysis of 4-Year Survival With Nivolumab Therapy in Patients With Previously Treated Advanced NSCLC
In an analysis reported in The Lancet Oncology, Antonia et al identified long-term survival rates with nivolumab therapy in patients with previously treated advanced non–small cell lung cancer (NSCLC). The pooled analysis included data from the CheckMate 017, 057, 063, and 003 trials, each...
Immune-Related Adverse Events Requiring Hospitalization in Patients Receiving Immune Checkpoint Inhibitors
In a single-center analysis reported in the Journal of Oncology Practice, Balaji et al found that immune-related adverse events associated with immune checkpoint inhibitor treatment often require hospitalization and multidisciplinary management. The study involved data from patients who had...
CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries
On August 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to...
Comparison of Biomarker Assay Types in Predicting Response to Anti–PD-1/PD-L1 Treatment
In a systematic review and meta-analysis reported in JAMA Oncology, Lu et al found that multiplex immunohistochemistry/immunofluorescence (mIHC/IF) assays appeared to have greater accuracy vs other types of assays in predicting response to anti–programmed cell death protein 1/programmed cell...
Maintenance Bevacizumab, Pemetrexed, or Both in Advanced Nonsquamous NSCLC
In the phase III ECOG-ACRIN 5508 trial, reported in the Journal of Clinical Oncology by Ramalingam et al, maintenance pemetrexed or bevacizumab was associated with no significant improvement in overall survival vs the bevacizumab control group alone, and was associated with greater toxicity in...
What Causes Liver Injury During Treatment With Pembrolizumab?
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a...
Cell-Free DNA Sequencing Highly Concordant With Tissue-Based Testing in the Detection of Microsatellite Instability Status
Microsatellite instability (MSI) is an important predictive biomarker of response to immune checkpoint blockade in solid cancers. However, despite recommendations by clinical practice guidelines, MSI is often not assessed, usually due to tissue insufficiency, unavailability, or infeasibility....
Ibrutinib/Rituximab vs Standard Chemoimmunotherapy in Previously Untreated CLL
In an interim analysis of the phase III E1912 trial reported in The New England Journal of Medicine, Shanafelt et al found that ibrutinib/rituximab improved progression-free and overall survival vs standard chemoimmunotherapy in patients 70 years old or younger with previously untreated chronic...
Tumor-Associated Antigen Cytotoxic T Cells in Relapsed or Refractory Solid Tumors
In a phase I trial reported in the Journal of Clinical Oncology, Hont et al found that treatment of relapsed or refractory solid tumors with ex vivo expanded autologous multiantigen-associated specific cytotoxic T cells—or, tumor-associated antigen cytotoxic T cells—was safe and showed...
FDA Pipeline: Breakthrough Therapy for Melanoma, Investigational New Drug for Advanced Solid Tumors
This week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bempegaldesleukin in combination with nivolumab for advanced melanoma and cleared an investigational new drug application for a phase I trial of SB 11285 in advanced solid tumors. Breakthrough...
Post Hoc 5-Year Follow-up of Pembrolizumab vs Ipilimumab in Advanced Melanoma
In a post hoc 5-year follow-up of the KEYNOTE-006 trial reported in The Lancet Oncology, Robert et al found that pembrolizumab maintained overall and progression-free survival benefits over ipilimumab in patients with advanced melanoma. In the primary analysis from the trial, both pembrolizumab...
Durvalumab With or Without Tremelimumab in Metastatic Pancreatic Cancer
In the first stage of a phase II trial reported in JAMA Oncology, O’Reilly et al found poor activity of durvalumab with or without tremelimumab in metastatic pancreatic ductal adenocarcinoma. Owing to the lack of efficacy, study expansion was not pursued. The lead-in open-label safety ...
Palbociclib Plus Cetuximab in Platinum- and Cetuximab-Resistant HPV-Unrelated Head and Neck Cancer
In a phase II study reported in The Lancet Oncology, Adkins et al found that the combination of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib and the EGFR inhibitor cetuximab showed activity in patients with either platinum- or cetuximab-resistant human papillomavirus...
FDA Approves Pembrolizumab for Some Patients With PD-L1–Positive Esophageal Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed ...
Rituximab Maintenance in Previously Untreated Follicular Lymphoma: 9-Year Follow-up
As reported in the Journal of Clinical Oncology by Bachy et al, 9-year follow-up of the phase III PRIMA trial indicated a maintained progression-free survival benefit of maintenance rituximab vs observation following first-line induction therapy for follicular lymphoma. As in the prior reports from ...
Five-Year Survival in Heavily Pretreated Patients Receiving Nivolumab Monotherapy
As reported by Topalian et al in JAMA Oncology, long-term follow up of patients from a phase I expansion cohort study indicated 5-year overall survival rates of 34.2%, 27.7%, and 15.6% among patients who received nivolumab monotherapy for advanced melanoma, renal cell carcinoma (RCC), and...
FDA Pipeline: Label Update for Durvalumab in NSCLC; Applications Accepted in Epithelioid Sarcoma, AML
Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...
Pembrolizumab After Stereotactic Body Radiotherapy in Advanced NSCLC
In a Dutch phase II study reported in JAMA Oncology, Theelen et al found that although use of stereotactic body radiotherapy prior to pembrolizumab increased the objective response rate vs pembrolizumab alone in metastatic non–small cell lung cancer (NSCLC), the difference did not meet study...
FDA Grants Breakthrough Therapy Designation to Pembrolizumab Plus Lenvatinib in Advanced HCC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the programmed cell death protein 1 inhibitor pembrolizumab in combination with the multiple kinase inhibitor lenvatinib for the potential first-line treatment of patients with advanced unresectable...
Immunotherapy After Locally Ablative Therapy for Oligometastatic NSCLC
In a single-center phase II trial reported in JAMA Oncology, Bauml et al found that pembrolizumab given after locally ablative therapy appeared to be associated with improved outcomes in patients with oligometastatic non–small cell lung cancer (NSCLC). In the study, 45 evaluable...
Maintenance Panitumumab vs Panitumumab/Fluorouracil/Leucovorin in RAS Wild-Type Metastatic Colorectal Cancer
In an Italian phase II trial reported in JAMA Oncology, Pietrantonio et al found that maintenance panitumumab alone was inferior in terms of progression-free survival (PFS) compared to maintenance panitumumab plus fluorouracil/leucovorin in RAS wild-type metastatic colorectal cancer. Study Details ...
Ramucirumab Plus Pembrolizumab in Previously Treated Advanced Gastroesophageal Cancer, NSCLC, and Urothelial Carcinoma
Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...
Incidence of Olaratumab Infusion-Related Reactions
In a study reported in the Journal of Oncology Practice, Van Tine et al found that infusion-related reactions occurred in 14.4% of patients receiving olaratumab in clinical trials, with grade ≥ 3 events occurring in 2.3%. (Olaratumab was withdrawn from the global market on April 25, 2019, based...
Immune Checkpoint Inhibitor Rechallenge After Immune-Related Adverse Events
In a study reported in JAMA Oncology, Simonaggio et al found that rechallenge with an immune checkpoint inhibitor after occurrence of immune-related adverse events was associated with occurrence of an immune-related adverse event in approximately half of patients, with no increase in severity....
Benefit Seen With Targeted Therapies in Elderly and Medically Complex Patients With Metastatic RCC
Many elderly and medically complex patients with metastatic renal cell carcinoma (RCC)—who are often underrepresented in clinical trials—saw overall survival benefits from treatment with targeted therapies, according to a study that analyzed 13 years of data on Medicare patients...
GOG-0218: Final Overall Survival Results for Addition of Bevacizumab to Chemotherapy in Ovarian Cancer
The final overall survival analysis of the phase III GOG-0218 trial, reported in the Journal of Clinical Oncology by Tewari et al, showed no benefit of adding bevacizumab to chemotherapy in women with newly diagnosed, incompletely resected, advanced ovarian cancer. The trial included 1,873 women...
Activity of Niraparib Plus Pembrolizumab in Recurrent Ovarian Carcinoma
In a pooled analysis of the phase I/II TOPACIO/KEYNOTE-162 study reported in JAMA Oncology, Konstantinopoulos et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with recurrent ovarian carcinoma. Study Details The analysis included 60 evaluable women...
Treatment of Immune Checkpoint Inhibitor Immune-Related Cutaneous Adverse Events
In a study reported in the Journal of Clinical Oncology, Phillips et al found that immune-related cutaneous adverse events in patients receiving immune checkpoint inhibitors generally responded to symptom- and phenotype-directed dermatologic therapies, and that biologic therapies were effective in...
ECHO-301/KEYNOTE-252: Addition of Epacadostat to Pembrolizumab in Unresectable or Metastatic Melanoma
As reported in The Lancet Oncology by Long et al, the phase III ECHO-301/KEYNOTE-252 trial showed no improvement in progression-free or overall survival with the addition of the IDO1 inhibitor epacadostat to pembrolizumab in unresectable stage III or stage IV melanoma. Study Details In the...
Multidisciplinary Approach for Addressing Immunotherapy-Related Toxicities
New research published in JNCCN—Journal of the National Comprehensive Cancer Network and presented by Jarushka Naidoo, MBBCh, at the NCCN 2019 Annual Conference suggests that institutions and networks that utilize immunotherapy should consider establishing multidisciplinary teams for...
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...
15-ICML: Final Data From ALCANZA: Brentuximab Vedotin for CD30-Positive CTCL
Final analyses from the ALCANZA study, a phase III trial investigating brentuximab vedotin vs physician’s choice for the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL), were presented by Horwitz et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract...
Outcomes of Immune Checkpoint Inhibitor Treatment in Patients With Advanced NSCLC Receiving Baseline Corticosteroids
In a single-center study reported in the Journal of Clinical Oncology, Ricciuti et al found better outcomes with immune checkpoint inhibitor treatment among patients with advanced non–small cell lung cancer (NSCLC) receiving baseline prednisone equivalent of ≥ 10 mg daily for...
Niraparib Plus Pembrolizumab in Advanced Triple-Negative Breast Cancer
In the phase II TOPACIO/KEYNOTE-162 trial reported in JAMA Oncology, Vinayak et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with advanced or metastatic triple-negative breast cancer, with higher response rates seen in patients with BRCA mutations or ...
15-ICML: Post Hoc Analysis of MAVORIC Study: Mogamulizumab in Patients With Previously Treated Cutaneous T-Cell Lymphoma
The MAVORIC study—presented by Scarisbrick et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 034)—examined the efficacy of mogamulizumab, a monoclonal antibody that targets the CC chemokine receptor 4 (CCR4), in patients with previously treated mycosis...
Activity of Nivolumab for Renal Cell Carcinoma Brain Metastases
In an analysis of the phase II GETUG-AFU 26 NIVOREN study reported in the Journal of Clinical Oncology, Flippot et al found that nivolumab had limited activity in patients with previously untreated brain metastases from clear cell renal cell carcinoma. The study assessed nivolumab in patients with ...
