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The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden...
In the phase III DERMA trial reported in The Lancet Oncology, Dreno et al found that an adjuvant MAGE-A3 immunotherapeutic provided no benefit vs placebo in patients with resected MAGE-A3–positive stage IIIB or IIIC melanoma. Development of the agent for use in melanoma has been stopped. The ...
In the phase III LILAC equivalence trial reported in The Lancet Oncology, von Minckwitz et al found similar efficacy and safety with the trastuzumab biosimilar ABP 980 vs reference trastuzumab (Herceptin) in HER2-positive early breast cancer. On local review, the risk difference and risk ratio (RR) ...
As reported in The Lancet by Shitara et al, the phase III KEYNOTE-061 trial showed no significant overall survival benefit with pembrolizumab vs paclitaxel in patients with advanced gastric or gastroesophageal junction cancer progressing on platinum-fluoropyrimidine treatment with programmed cell...
As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...
In an analysis of the GALLIUM trial reported in the Journal of Clinical Oncology, Hiddemann and colleagues found that obinutuzumab (Gazyva) appeared to provide consistent progression-free survival benefit vs rituximab (Rituxan) in previously untreated follicular lymphoma, irrespective of which...
As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by Socinski et al, the phase III IMpower150 trial has shown that the addition of atezolizumab (Tecentriq) to bevacizumab (Avastin) plus chemotherapy significantly improved progression-free and overall survival in ...
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). KEYNOTE-021 This...
The addition of durvalumab -(Imfinzi) to anthracycline/taxane-based chemotherapy had encouraging results as neoadjuvant therapy for early triple-negative breast cancer in the randomized phase II GeparNuevo study presented at the 2018 ASCO Annual Meeting.1 The results were positive in a subgroup of...
As reported at the 2018 ASCO Annual Meeting (Abstract 9519) and in The New England Journal of Medicine by Migden et al, results of early-phase testing show activity of the programmed cell death protein 1 (PD-1) inhibitor cemiplimab in advanced cutaneous squamous cell carcinoma. Currently, no...
Fourteen-month results from the JULIET clinical trial showed ongoing durable responses are achievable with tisagenlecleucel (Kymriah) when administered to adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This updated analysis was presented by Borchmann et al at ...
Data from the final analysis of the CLL11 study evaluating obinutuzumab (Gazyva)-based treatment in previously untreated chronic lymphocytic leukemia (CLL) was presented by Goede et al during the Presidential Symposium at the 23rd Annual Congress of the European Hematology Association (EHA)...
As reported in The Lancet Oncology by Zhu et al, the phase II KEYNOTE-224 study has shown activity of pembrolizumab in advanced hepatocellular carcinoma (HCC) pretreated with sorafenib. Study Details In the study, 104 eligible patients who were intolerant of or progressed on sorafenib were...
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or those who have relapsed after two or more prior lines of therapy. KEYNOTE-170...
Today, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel) followed by bevacizumab as a single agent for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection....
The phase III iLLUMINATE (PCYC-1130) trial recently met its primary endpoint of improvement in progression-free survival. The study evaluated ibrutinib (Imbruvica) in combination with obinutuzumab (Gazyva) in patients with previously untreated chronic lymphocytic leukemia or small lymphocytic...
On June 12, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with recurrent or metastatic cervical cancer and disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1) [Combined Positive Score...
Recent research has shown that the tumor microenvironment in older patients promoted melanoma metastasis and resistance to targeted therapy with a BRAF inhibitor. Now, a new study investigating the relationships among age, response to anti–programmed cell death protein 1 (PD-1)...
In a letter to the editor in The New England Journal of Medicine, Ratner et al describe rapid progression of adult T-cell leukemia/lymphoma (ATLL) in three consecutive patients receiving programmed cell death protein 1 (PD-1) inhibitor therapy with nivolumab (Opdivo). As stated by the authors,...
Results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented by Fowler et al at the 2018 ASCO Annual Meeting (Abstract 7005). This study evaluated the investigational...
Results from KEYNOTE-407, a randomized, double-blind, placebo-controlled, phase III study evaluating pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or carboplatin/nab-paclitaxel (Abraxane) as first-line treatment for metastatic squamous non–small cell lung cancer...
For patients with multiple myeloma who have been treated with lenalidome (Revlimid) but have relapsed and not responded to other therapy, a three-drug combination can significantly extend the time in which the disease is held in check. The findings of the phase III OPTIMISMM trial were presented by ...
Interim results from cohort A of KEYNOTE-427, a phase II trial evaluating pembrolizumab (Keytruda) as first-line treatment for advanced clear cell renal cell carcinoma (RCC), were presented by McDermott et al at the 2018 ASCO Annual Meeting (Abstract 4500). Interim data showed an overall response...
In a retrospective cohort study reported in JAMA Oncology, O’Connor et al found that anti–programmed cell death protein 1 (PD-1) agents rapidly reached eligible patients after U.S. Food and Drug Administration (FDA) approval. The study also showed that real-world patients were...
Updated efficacy and safety data from the international, multicenter JAVELIN Merkel 200 trial of avelumab (Bavencio) in patients with metastatic Merkel cell carcinoma were presented by Nghiem et al at the 2018 ASCO Annual Meeting (Abstract 9507). 2-Year Follow-up At the 2-year follow-up update of ...
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, and Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, offer their analysis of two key studies presented in renal cell cancer.
Juliet Elizabeth Wolford, MD, of the University of California, Irvine, discusses the cost-effectiveness of various types of maintenance therapy in advanced ovarian cancer: paclitaxel, bevacizumab, niraparib, rucaparib, olaparib, and pembrolizumab (Abstract 5508).
Robert L. Coleman, MD, of The University of Texas MD Anderson Cancer Center, discusses phase III study findings on secondary surgical cytoreduction followed by platinum-based combination chemotherapy, with or without bevacizumab, in platinum-sensitive, recurrent ovarian cancer (Abstract 5501).
Howard S. Hochster, MD, of Rutgers-Cancer Institute of New Jersey, discusses study findings on irinotecan and cetuximab vs irinotecan, cetuximab, and ramucirumab as second-line therapy of advanced colorectal cancer following oxaliplatin and bevacizumab-based therapy (Abstract 3504).
Results from a preplanned interim analysis of the phase III iNNOVATE (PCYC-1127) study evaluating the investigational use of ibrutinib (Imbruvica) in combination with rituximab (Rituxan) in relapsed/refractory and treatment-naive patients with Waldenström’s macroglobulinemia were...
Sibylle Loibl, MD, PhD, of the German Breast Group, discusses phase II study findings on the addition of durvalumab to a taxane-anthracycline–containing chemotherapy in triple-negative breast cancer (Abstract 104).
Toni K. Choueiri, MD, and Lauren C. Harshman, MD, both of Dana-Farber Cancer Institute, discuss phase III study findings on perioperative nivolumab vs observation in patients with localized renal cell carcinoma undergoing nephrectomy (Abstract TPS4597).
Bernard J. Escudier, MD, of Gustave Roussy, discusses patient-reported outcomes for atezolizumab plus bevacizumab vs sunitinib in treatment-naive metastatic renal cell carcinoma (Abstract 4511).
Ursula A. Matulonis, MD, of Dana-Farber Cancer Institute, and Stéphanie Gaillard, MD, PhD, of Duke Cancer Institute, discuss an evaluation of bevacizumab in the primary treatment of advanced ovarian cancer (Abstract 5517).
Laurie Helen Sehn, MD, MPH, of the British Columbia Cancer Centre for Lymphoid Cancer, discusses phase II study findings on polatuzumab vedotin with bendamustine and rituximab in relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma (Abstract 7507).
David M. O’Malley, MD, of The Ohio State University College of Medicine, discusses phase Ib study findings on mirvetuximab soravtansine, a folate receptor alpha-targeting antibody-drug conjugate, in combination with bevacizumab in patients with platinum-resistant ovarian cancer (Abstract 5549).
Danny Rischin, MD, of Peter MacCallum Cancer Centre, discusses phase II study findings on cemiplimab, a human monoclonal anti–PD-1 antibody, in patients with metastatic cutaneous squamous cell carcinoma (Abstract 9519).
Helena Margaret Earl, MBBS, PhD, of the University of Cambridge, discusses phase III study findings on 6 vs 12 months of adjuvant trastuzumab in patients with HER2-positive early breast cancer (Abstract 506).
Peter Hillmen, MB, ChB, of St James’s University Hospital, discusses phase III study findings on minimal residual disease negativity with venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukemia (Abstract 7508).
David F. McDermott, MD, of Beth Israel Deaconess Medical Center, discusses study findings on pembrolizumab monotherapy as first-line therapy in advanced clear cell renal cell carcinoma (Abstract 4500).
Lee S. Schwartzberg, MD, of West Cancer Center, reports on the progress of the ACCC Immuno-Oncology Institute to speed adoption of immunotherapeutics in community practices.
Julie M. Vose, MD, MBA, of the University of Nebraska Medical Center, and Nathan Hale Fowler, MD, of The University of Texas MD Anderson Cancer Center, discuss phase III study findings on lenalidomide plus rituximab vs chemotherapy plus rituximab, followed by rituximab maintenance, in patients with previously untreated follicular lymphoma (Abstract 7500).
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, and Laurence Albiges, MD, PhD, of Gustave Roussy, discuss two treatment studies: one testing pegilodecakin with nivolumab or pembrolizumab and the other evaluating an oral CXCR4 inhibitor in combination with axitinib (Abstracts 4509 & 4510).
Gilberto Lopes, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, discusses phase III findings on pembrolizumab vs platinum-based chemotherapy as first-line treatment for advanced/metastatic non–small cell lung cancer with a PD-L1 tumor proportion score ≥ to 1% (Abstract LBA4).
A large, randomized phase III trial shows that the immunotherapy pembrolizumab (Keytruda) is a more effective initial treatment than chemotherapy (the current standard of care) for the majority of patients with the most common type of lung cancer. People with advanced non–small cell lung...
Robert M. Jotte, MD, PhD, of Rocky Mountain Cancer Centers, discusses phase III study findings on atezolizumab plus carboplatin plus paclitaxel or nab-paclitaxel vs carboplatin plus nab-paclitaxel, as first-line therapy in advanced squamous non–small cell lung cancer (Abstract LBA9000).
Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, discusses phase III findings on ibrutinib/rituximab vs placebo/rituximab in Waldenström’s macroglobulinemia (Abstract 8003).
Initial findings from a randomized phase III clinical trial showed that patients with advanced squamous non–small cell lung cancer (NSCLC) benefit more from initial treatment with the programmed cell death ligand 1 (PD-L1)-targeted immunotherapy atezolizumab (Tecentriq) and chemotherapy than...
In a study reported in the Journal of Clinical Oncology, Leonardi et al found that programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitor monotherapy in patients with non–small cell lung cancer (NSCLC) and autoimmune disorders worsened such disorders in a...
On May 18, the U.S. Food and Drug Administration (FDA) alerted health-care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of pembrolizumab (Keytruda) or atezolizumab (Tecentriq) as monotherapy in clinical trials to treat patients with ...