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In a phase Ib trial reported in The Lancet Oncology, Naing et al found that the combination of pegilodecakin (pegylated interleukin [IL]-10) with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab or nivolumab was active in previously treated advanced solid tumors. In the study,...
As reported in The Lancet Oncology by Kato et al, the phase III ATTRACTION-3 trial conducted in predominantly Asian patients has shown a survival benefit with nivolumab vs paclitaxel or docetaxel in patients with advanced esophageal squamous cell carcinoma who were refractory to or intolerant of...
The management of rectal cancer has evolved over the past decades, yielding several major practice changes that have substantially improved outcomes. However, rectal cancer treatment remains challenging and even with improved outcomes can result in life-altering morbidity. To shed light on the...
Jorge J. Castillo, MD, of Dana-Farber Cancer Institute, discusses the many advances in treating relapsed and/or refractory multiple myeloma, including novel immunomodulators, proteasome inhibitors, and monoclonal antibodies, as well as emerging treatments such as chimeric antigen receptor T-cell therapy and antibody-drug conjugates.
Richard I. Fisher, MD, of Fox Chase Cancer Center, discusses the improvement in survival for patients with follicular lymphoma, new targeted biologic agents providing alternative treatments, and chemoimmunotherapy (a standard in many cases).
Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses the debate on evolving strategies in first-line treatment of CLL.
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, offers commentary on the debate about evolving strategies in first-line chronic lymphocytic leukemia, the clinical trials on such agents as ibrutinib, BTK inhibitors, and venetoclax, and the interest in chemoimmunotherapy as a fixed duration treatment.
In an interim analysis of the phase III BEACON CRC trial reported at the European Society for Medical Oncology (ESMO) Congress 2019 (Abstract LBA32) and in The New England Journal of Medicine, Scott Kopetz, MD, PhD, and colleagues found improved overall survival and overall response rate in...
As reported at the European Society for Medical Oncology (ESMO) Congress 2019 (Abstract LBA4) and simultaneously in The New England Journal of Medicine by Matthew D. Hellmann, MD, and colleagues, the phase III CheckMate 227 trial has shown that nivolumab plus ipilimumab improved overall survival vs ...
In a phase II study reported in the Journal of Clinical Oncology, Khodadoust et al found that pembrolizumab was active in patients with advanced relapsed or refractory mycosis fungoides or Sézary syndrome. In the U.S.-based multicenter trial, 24 patients with advanced mycosis fungoides (n = 9) or...
Formal discussant Myung-Ju Ahn, MD, of Samsung Medical Center Sungkyunkwan University, Seoul, South Korea, said that the CASPIAN results were similar to those of IMpower133, which found that the addition of the immune checkpoint inhibitor atezolizumab to etoposide/carboplatin significantly...
A meta-analysis of 16 phase III randomized clinical trials evaluating programmed cell death protein 1/ligand 1 (PD-1/-L1) inhibitors either alone or in combination with chemotherapy for solid tumors has found that women derived significantly greater benefit from the addition of chemotherapy to...
Superior recurrence-free survival benefit was observed with nivolumab vs ipilimumab—and was consistent across disease stage, programmed cell death ligand 1 (PD-L1) expression levels, and BRAF mutation status—in patients with resected stage III/IV melanoma and a high risk of recurrence, according to ...
Patients with locally advanced or metastatic urothelial carcinoma demonstrated prolonged progression-free survival with the addition of atezolizumab to first-line platinum-based chemotherapy vs treatment with chemotherapy alone, according to phase III data from the IMvigor130 study presented by...
Nicoletta Colombo, MD, of Istituto Europeo di Oncologia, discusses the efficacy of lenvatinib/pembrolizumab in metastatic endometrial cancer. The combination showed antitumor activity, regardless of tumor microsatellite instability or DNA mismatch repair status (Abstract 994O).
Thomas Powles, MD, PhD, of Queen Mary University of London, and Enrique Grande, MD, PhD, of MD Anderson Cancer Center, Madrid, discuss findings of the phase III IMvigor130 trial on the efficacy and safety of atezolizumab as monotherapy or combined with platinum-based chemotherapy vs placebo plus platinum-based chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (Abstract LBA14).
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 therapy in newly diagnosed advanced disease); and the VELIA/COG-3005 study (integrating veliparib with front-line chemotherapy and maintenance therapy) (Abstracts LBA 1–4).
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, 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 were reported (Abstract 1311O).
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, 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, 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 advanced breast cancer (Abstract 305O).
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 early triple-negative breast cancer (Abstract LBA8).
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 progression-free survival, with the greatest benefit in women with BRCA mutations and positive homologous recombination deficiency status (Abstract LBA2).
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 (Abstract 902O).
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).
An update of results of the phase III CheckMate 067 trial at 5 years presented by Larkin et al at the European Society for Medical Oncology (ESMO) 2019 Congress showed that both nivolumab in combination with ipilimumab and nivolumab alone provided significant improvements in overall survival,...
New data have shown a trend toward clinically meaningful improvements in survival and response rates and a favorable safety profile with first-line immunotherapy compared to current standard treatment for advanced hepatocellular carcinoma (HCC). The data, reported by Yau et al at the European...
In a study presented in a brief report in JAMA Oncology, Pinato et al found that past—but not concurrent—use of broad-spectrum antibiotic therapy was associated with poorer treatment outcomes in patients receiving immune checkpoint inhibitors for various cancers in routine clinical practice. As...
In a pooled analysis reported in the Journal of Clinical Oncology, Regan et al evaluated treatment-free survival as an outcome measure among patients with advanced melanoma receiving nivolumab/ipilimumab or either agent alone in the CheckMate 067 and 069 trials. Study Details The study involved...
This past June, the University of Pennsylvania established the Mark Foundation Center for Immunotherapy, Immune Signaling, and Radiation to study the role interferon and pattern recognition receptor signaling transduction pathways play in modulating the immune system’s ability to recognize and...
As reported in the Journal of Clinical Oncology by Naumann et al, the phase I/II CheckMate 358 trial found that nivolumab showed activity in a cohort of patients with recurrent or metastatic cervical, vaginal, or vulvar squamous cell carcinoma. Study Details A total of 24 patients were enrolled...
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, 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).
Alex A. Adjei, MD, PhD, of Mayo Clinic, Rochester, Minnesota, who was not involved in KEYNOTE-189 or KEYNOTE-021, provided some perspective on the exploratory analyses of tumor mutational burden from these and other studies. “Four studies at this meeting presented data on tumor mutational burden...
In a research letter published in JAMA Oncology, Wang et al identified the frequency of mutations in DNA polymerase epsilon (POLE) and delta 1 (POLD1) genes across cancer types and found that these mutations were associated with better survival outcomes among patients receiving immune checkpoint...
Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, presented an update of the landmark PACIFIC trial at the 61st Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Abstract LBA-6). In earlier reports from the randomized phase III trial, Antonia et al had evaluated...
The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...
In the phase II NSGO-AVANOVA2/ENGOT-ov24 trial reported in The Lancet Oncology, Mansoor Raza Mirza, MD, and colleagues found that the combination of bevacizumab plus niraparib prolonged progression-free survival vs niraparib alone in women with platinum-sensitive recurrent ovarian cancer. Study...
Non–small cell lung cancer (NSCLC) accounts for the vast majority of all lung cancers—between 80% and 85% of those diagnosed in the United States—and is among the most deadly cancers for both men and women, exceeding the mortality rate of colon, breast, and pancreatic cancers combined. The results...
First-line pembrolizumab monotherapy provides durable long-term overall survival benefit compared to chemotherapy in patients with advanced non–small cell lung cancer (NSCLC), according to data from the KEYNOTE-024 trial presented by Martin Reck, MD, PhD, at the International Association for the...
Although studies have demonstrated that microsatellite instability (MSI) and high tumor mutational burden (TMB) are promising pan-tumor biomarkers for identifying patients for treatment with immune checkpoint blockade, obtaining tissue from unresectable or metastatic solid tumors for genetic...
Patients with stage IV squamous non–small cell lung cancer (NSCLC) with high programmed cell death ligand 1 (PD-L1) expression treated with atezolizumab and chemotherapy experienced longer overall survival rates than those treated with chemotherapy alone. The data from the IMpower131 trial were...
In an Australian phase Ia/b trial reported in The Lancet Oncology, Friedlander et al found evidence of activity of the combination of the poly (ADP-ribose) polymerase inhibitor pamiparib and the programmed cell death protein 1 inhibitor tislelizumab in patients with previously treated advanced...
In the phase Ib NSABP Foundation Trial FB-10 reported in the Journal of Clinical Oncology, Jame Abraham, MD, and colleagues found evidence of activity of the combination of ado-trastuzumab emtansine (T-DM1) plus neratinib in metastatic HER2-positive breast cancer and identified the dose of the...
The addition of durvalumab to chemotherapy improved overall survival in patients with extensive-stage small cell lung cancer (SCLC), according to research presented at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) (Abstract PL02.11)....
Pooled data on two clinical trials demonstrated patients with previously treated non–small cell lung cancer (NSCLC) treated with nivolumab had a greater than fivefold increase in 5-year overall survival rate compared to treatment with the chemotherapy docetaxel. Scott Gettinger, MD, of Yale...
On July 30, 2019, pembrolizumab was approved for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed cell death ligand 1 (PD-L1; Combined Positive Score [CPS] ≥ 10), as determined by a U.S. Food and Drug...
On June 10, 2019, pembrolizumab was approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.1,2 Pembrolizumab was approved for use in combination with platinum and fluorouracil (5-FU) for all patients and as a single agent...
On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase...