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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 ...
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).
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
EHA 2019: ASCEND Trial Compares Acalabrutinib vs Investigator’s Choice in Relapsed or Refractory CLL
The randomized, global, multicenter, open-label phase III ASCEND trial evaluated the efficacy and safety of acalabrutinib vs investigator’s choice of rituximab/idelalisib or rituximab/bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ghia et al presented ...
TONIC: PD-1 Blockade in Metastatic Triple-Negative Breast Cancer
Clinical and translational data from the TONIC trial, published in a research letter by Voorwerk et al in Nature Medicine, indicated that short-term doxorubicin and cisplatin may induce a more favorable tumor microenvironment and increase the likelihood of response to programmed cell death protein...
Peter Schmid, MD, PhD, and Hope S. Rugo, MD, on Breast Cancer: Next Steps in Immunotherapy
Hope S. Rugo, MD, of the University of California, San Francisco, and Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, discuss ongoing trials of immunotherapy for early triple-negative breast cancer; immunotherapy in other disease subtypes such as estrogen...
FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...
2019 ASCO: OPTiM Study on T-VEC for Unresectable Melanoma
New research on the immunotherapy talimogene laherparepvec (T-VEC)—an injectable oncolytic virus—for patients with unresectable melanoma was presented by Milhem et al at the 2019 ASCO Annual Meeting (Abstract 9524). Researchers reported the ad hoc analysis of progression-free survival...
Peter Schmid, MD, PhD, and Hope S. Rugo, MD, on Metastatic Triple-Negative Breast Cancer: Atezolizumab Plus Nab-paclitaxel
Hope S. Rugo, MD, of the University of California, San Francisco, and Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, discuss an update of the IMpassion130 interim overall survival analysis of atezolizumab plus nab-paclitaxel in previously untreated locally...
Hope S. Rugo, MD, and Matteo Lambertini, MD, PhD, on the SOPHIA Trial in HER2-Positive Metastatic Breast Cancer: Chemotherapy Plus Margetuximab vs Trastuzumab
Matteo Lambertini, MD, PhD, of the University of Genova and Policlinico San Martino Hospital, and Hope S. Rugo, MD, of the University of California, San Francisco, discuss findings from the SOPHIA trial on margetuximab plus chemotherapy vs trastuzumab plus chemotherapy in patients with...
Mansoor Raza Mirza, MD, and Don S. Dizon, MD, on Recurrent Platinum-Sensitive Ovarian Cancer: Niraparib Plus Bevacizumab
Don S. Dizon, MD, of the Lifespan Cancer Institute, and Mansoor Raza Mirza, MD, of Copenhagen University Hospital, discuss study findings that showed, compared with niraparib alone, niraparib plus bevacizumab improved progression-free survival in women with recurrent platinum-sensitive ovarian...
Sara A. Hurvitz, MD, on HER2-Positive Breast Cancer: KRISTINE Trial on Neoadjuvant Trastuzumab, Pertuzumab, and Chemotherapy
Sara A. Hurvitz, MD, of the David Geffen School of Medicine, University of California Los Angeles, discusses 3-year outcomes from the first phase III study to test a non-conventional regimen for the neoadjuvant and adjuvant treatment of HER2-positive breast cancer (Abstract 500).
2019 ASCO: Combination Therapy With SurVaxM in Newly Diagnosed Glioblastoma
Ahluwalia et al shared research results on SurVaxM at the 2019 ASCO Annual Meeting, reporting that combination therapy with the immunotherapy vaccine was more effective than standard therapy for nearly all patients with newly diagnosed glioblastoma in a phase II trial (Abstract 2016). SurVaxM...
FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was...
FDA Approves Polatuzumab Vedotin-piiq in Combination With Bendamustine and a Rituximab Product for DLBCL
On June 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
2019 ASCO: NEOSTAR: Neoadjuvant Nivolumab Plus Ipilimumab in Early-Stage, Resectable NSCLC
Neoadjuvant treatment with nivolumab plus ipilimumab resulted in an overall major pathologic response rate of 33% of treated patients with early-stage, resectable non–small cell lung cancer (NSCLC). With these results, the combination immunotherapy met the prespecified trial...
2019 ASCO: Rituximab, Lenalidomide, and Ibrutinib Prior to Chemotherapy in DLBCL
Results of the phase II Smart Start trial revealed that combination targeted therapy consisting of rituximab, lenalidomide, and ibrutinib had an 84.6% overall response rate (ORR) and 38.5% complete response rate (CRR) when given prior to any chemotherapy for newly diagnosed patients with a...
Jason Westin, MD, on Diffuse Large B-Cell Lymphoma: Rituximab, Lenalidomide, and Ibrutinib Prior to Chemotherapy
Jason Westin, MD, of The University of Texas MD Anderson Cancer Center, discusses findings of the Smart Start study on the chemotherapy-free combination of rituximab, lenalidomide, and ibrutinib in newly diagnosed diffuse large B-cell lymphoma (Abstract 7508).
William G. Wierda, MD, PhD, on Immunotherapy for Relapsed/Refractory CLL/SLL: Results From TRANSCEND CLL 004
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the TRANSCEND CLL 004 trial, which studied the use of an experimental CD19-directed CAR T-cell product in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (Abstract ...
Ahmad A. Tarhini, MD, PhD, on High-Risk Melanoma: Adjuvant Ipilimumab vs High-Dose Interferon-α2b
Ahmad A. Tarhini, MD, PhD, of Emory University and Winship Cancer Institute, discusses phase III findings from the U.S. Intergroup E1609 trial, which showed survival benefits for patients with resected high-risk melanoma—for the first time in the history of melanoma adjuvant therapy (Abstract...
Javier Sastre, MD, PhD, on Colorectal Cancer: Bevacizumab and FOLFOXIRI in Metastatic Disease
Javier Sastre, MD, PhD, of Hospital Clinico San Carlos, discusses phase III findings on the assessment of circulating tumor cells as a prognostic factor and FOLFOXIRI plus bevacizumab combination outcomes for patients with poor-prognosis colorectal cancer (Abstract 3507).
William D. Tap, MD, on Soft-Tissue Sarcomas: ANNOUNCE Trial on Doxorubicin and Olaratumab
William D. Tap, MD, of Memorial Sloan Kettering Cancer Center, discusses negative study findings on doxorubicin plus olaratumab vs doxorubicin plus placebo, which showed no difference in overall survival between the two treatments in patients with advanced soft-tissue sarcomas. The manufacturer is...
Gilberto Lopes, MD, MBA, on the RELAY Trial in Metastatic NSCLC: Erlotinib and Ramucirumab in EGFR Mutant–Positive Disease
Gilberto Lopes, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, offers commentary on phase III findings from the RELAY study, which showed that erlotinib plus ramucirumab led to superior progression-free survival in previously untreated patients with EGFR...
Ziad Bakouny, MD, and Toni K. Choueiri, MD, on Renal Cell Carcinoma: Checkpoint Inhibitors and Genomic Characterization of Sarcomatoid/Rhabdoid Disease
Toni K. Choueiri, MD, and Ziad Bakouny, MD, both of Dana-Farber Cancer Institute, discuss a retrospective review of genomically profiled patients with sarcomatoid/rhabdoid renal cell cancer who were found to have better outcomes with immune checkpoint inhibitors and to harbor mutations associated...
Sarah Abou Alaiwi, MD, and Toni K. Choueiri, MD, on Checkpoint Inhibitors: Overall Survival and Polybromo-Associated Mutations
Toni K. Choueiri, MD, and Sarah Abou Alaiwi, MD, both of Dana-Farber Cancer Institute, discuss the association of polybromo-associated BAF-type mutations with overall survival in patients with different solid tumors treated with checkpoint inhibitors (Abstract 103).
Paul G. Richardson, MD, on Relapsed or Refractory Multiple Myeloma: Adding Isatuximab to Pomalidomide and Low-Dose Dexamethasone
Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses findings from the phase III ICARIA-MM trial showing that isatuximab, pomalidomide, and low-dose dexamethasone significantly improved progression-free survival and overall response vs pomalidomide and dexamethasone (Abstract 8004).
Miriam Knoll, MD, and Richard J. White, DO, on Non–Small Cell Lung Cancer: Predicting Radiotherapy/Immunotherapy Treatment Outcomes
Miriam Knoll, MD, of Hackensack University Medical Center, and Richard J. White, DO, of Allegheny Health Network, discuss improved overall survival among younger female patients with non–small cell lung cancer who have a lower comorbidity score, lower grade, private insurance, and treatment with...
Yoland C. Antill, MD, on Endometrial Cancer: PHAEDRA Trial on Durvalumab and Mismatch Repair Status
Yoland C. Antill, MD, of Cabrini Health, discusses phase II data on the effect of durvalumab, a PD-L1 inhibitor, as a single agent in the setting of recurrent or advanced endometrial cancer. Her research compares the response in mismatch repair–deficient and –proficient tumors (Abstract 5501).
Suresh S. Ramalingam, MD, on Non–Small Cell Lung Cancer: Pemetrexed, Bevacizumab, or Both as Maintenance Therapy
Suresh S. Ramalingam, MD, of Winship Cancer Institute, Emory University, discusses findings from the ECOG-ACRIN 5508 study, which showed that single-agent bevacizumab or pemetrexed is the optimal maintenance therapy for advanced nonsquamous NSCLC (Abstract 9002).
Matt D. Galsky, MD, on Urothelial Cancer: Pembrolizumab vs Placebo After First-Line Chemotherapy
Matt D. Galsky, MD, of The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, discusses phase II study findings that show switch maintenance with pembrolizumab significantly improves progression-free survival in the metastatic setting (Abstract 4504).
Jonathan E. Rosenberg, MD, on Urothelial Carcinoma: Adding Bevacizumab to Gemcitabine and Cisplatin
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses results from the phase III Alliance trial, which showed that adding bevacizumab to gemcitabine and cisplatin did not improve overall survival in patients with metastatic urothelial carcinoma, but did improve...
