On March 20, Genentech announced that the phase III IMpower131 study met its coprimary endpoint of progression-free survival (PFS) and demonstrated that the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and nanopartical albumin-bound [nab]-paclitaxel [Abraxane])...
“At Microphone 1” is an occasional column written by Steven E. Vogl, MD, of the Bronx, New York. When he is not in his clinic, he can generally be found at major oncology meetings and often at the microphone, where he stands ready with critical questions for presenters of new data. The opinions...
CD19-DIRECTED chimeric antigen receptor (CAR) T-cell therapy has been approved by the U.S. Food and Drug Administration for the treatment of leukemia (tisagenlecleucel [Kymriah]) and lymphoma (axicabtagene ciloleucel [Yescarta]), but another type of CAR T-cell therapy is generating interest as a...
In the phase III COLUMBUS trial reported in The Lancet Oncology, Dummer et al found that the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved progression-free survival vs vemurafenib (Zelboraf) in patients with advanced BRAF V600–mutant melanoma....
In an Australia-New Zealand phase III trial (Trans Tasman Radiation Oncology Group 05.01) reported in the Journal of Clinical Oncology, Porceddu et al found no benefit of adding carboplatin to postoperative radiation therapy in patients with high-risk cutaneous squamous cell carcinoma of the head...
In a phase III trial (SUMIT) reported in the Journal of Clinical Oncology, Carvajal et al found that the addition of the oral MEK1/2 inhibitor selumetinib to dacarbazine did not significantly improve progression-free survival in patients with metastatic uveal melanoma. Study Details In the...
On March 19, a supplemental New Drug Application (sNDA) for enzalutamide (Xtandi) was accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). If approved, the sNDA would expand the indication of enzalutamide to include men with nonmetastatic...
On March 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. “Today’s approval represents an improvement in the initial...
In the dose-finding, dose-expansion phase Ib JAVELIN Renal 100 trial reported in The Lancet Oncology, Choueiri et al identified the maximum tolerated dose of the immune checkpoint inhibitor avelumab (Bavencio) in combination with the vascular endothelial growth factor inhibitor axitinib...
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, present information on...
Triplet therapy that inhibits the BRAF, MEK, and epidermal growth factor receptor (EGFR) pathways appears promising in BRAF-mutated colorectal cancer, a malignancy that typically does not respond to BRAF inhibition alone. Early results from the BEACON CRC study showed a 48% response rate and an...
Along with full coverage of key presentations from the 2018 Gastrointestinal Cancers Symposium, The ASCO Post brings our readers this additional news roundup. Side Matters in Colon Cancer One of the studies included in the global IDEA trial, which compared 3 vs 6 months of adjuvant chemotherapy in ...
The combination of axitinib (Inlyta) plus pembrolizumab (Keytruda) can be added to the list of combination therapies that look promising in advanced renal cell carcinoma. In a phase Ib trial, almost three-quarters of patients with newly diagnosed advanced renal cell carcinoma treated with the...
Patients with recurrent urothelial cancer had sustained improvement in overall survival at 2 years after they received second-line treatment with pembrolizumab (Keytruda) vs chemotherapy, according to an updated survival analysis of the phase III KEYNOTE-045 trial presented at the 2018...
The moderator of the session, Francis P. Worden, MD, a medical oncologist at the University of Michigan Health System Comprehensive Cancer Center, in Ann Arbor, highlighted the number of poorly differentiated carcinomas, which is higher than reported in other previous, large studies. “In previous...
Cabozantinib (Cometriq) has demonstrated significant activity in the first-line setting for radioiodine-refractory differentiated thyroid carcinoma, according to data from a single-site phase II trial presented at the 2018 Multidisciplinary Head and Neck Cancers Symposium.1 Treatment with...
In an analysis of two pooled studies reported in JAMA Oncology, O’Brien et al found that a complete response to ibrutinib (Imbruvica) in the treatment of chronic lymphocytic leukemia was more likely in patients receiving the agent as first-line therapy and in those without bulky disease....
In an investigator-initiated phase III SIRveNIB trial in Asia-Pacific patients reported in the Journal of Clinical Oncology, Chow et al found no difference in overall survival with selective internal radiation therapy, or radioembolization, vs sorafenib (Nexavar) in patients with unresectable...
As reported in The Lancet Oncology by Tang et al, a Chinese phase III noninferiority trial has shown similar progression-free survival with nedaplatin- vs cisplatin-based chemoradiotherapy in patients with stage II to IVB nasopharyngeal carcinoma, with nedaplatin being associated with fewer severe...
The French phase III ALLOZITHRO trial, stopped early due to excessive hematologic relapse in the azithromycin group, showed worse airflow decline–free survival with azithromycin vs placebo after hematopoietic stem cell transplantation (HSCT) for hematologic malignancy. The study findings were...
Breast cancer specialist Stacy L. Moulder, MD, was born and reared in Brookhaven, Mississippi, a small town southwest of the state capital of Jackson. “I was always interested in math and science, and I had a wonderful biology teacher in high school. It was when the advanced placement courses...
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 December 19, 2017, bosutinib (Bosulif) was granted...
AS REPORTED in The New England Journal of Medicine by Jean-Charles Soria, MD, PhD, of Gustave Roussy Cancer Campus and University Paris-Sud, and colleagues, the phase III FLAURA trial has shown a significant progression-free survival benefit with the third-generation epidermal growth factor...
EACH YEAR, The ASCO Post asks Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, to give his picks for the most important research presented at the San Antonio Breast Cancer...
FOR NEWLY DIAGNOSED patients with multiple myeloma considered to be at high risk of disease progression, double autologous stem cell transplantation (ASCT) significantly prolongs progression-free and overall survival, vs single transplant, according to the phase III EMN02/HO95 study. The findings...
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Ting Bao, MD, DABMA, MS, reviews the current data on the use of acupuncture...
On January 26, 2018, the radiolabeled somatostatin analog lutetium Lu-177 dotatate (Lutathera) was approved for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.1,2 Supporting...
In a phase III trial (BrighTNess) reported in The Lancet Oncology, Loibl et al found that the addition of the PARP inhibitor veliparib to carboplatin and paclitaxel in neoadjuvant therapy did not increase pathologic complete response rate in women with triple-negative breast cancer. Study Details ...
ADJUVANT CHEMOTHERAPY achieved robust improvements in disease-free survival and metastasis-free survival compared with surveillance in the phase III POUT study of patients with upper tract urothelial cancer.1 Further, there was an early trend toward improved overall survival with adjuvant...
IN PATIENTS WITH metastatic pancreatic adenocarcinoma, 1-year survival reached 43% following treatment with a novel immunotherapy—PEGylated human IL-10 (AM0010, pegilodecakin)—plus chemotherapy, in a small study reported at the 2018 Gastrointestinal Cancers Symposium.1 “We saw a very high disease...
LISOCABTAGENE MARALEUCEL (Liso-cel; JCAR017), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy with defined composition, has shown “potent and durable” responses in poor-prognosis patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) in a phase I trial.1 According ...
ON OCTOBER 17, 2017, Norman E. Sharpless, MD, became the 15th Director of the National Cancer Institute (NCI), succeeding Harold E. Varmus, MD, who stepped down as Director of the agency in March 2015, and replacing Douglas R. Lowy, MD, who had served as Acting Director for 2 years. The...
THE TYROSINE KINASE inhibitor sunitinib (Sutent) has been the mainstay of treatment for first-line treatment of advanced renal cell carcinoma for about a decade. The IMmotion151 study reported at the 2018 Genitourinary Cancers Symposium found that the combination of the immune checkpoint inhibitor...
FOR DECADES, the status of metastatic prostate cancer trials was not particularly exciting. With an absence of high-impact novel agents, the focus of cancer trial groups was on the improvement of standard care. Well-crafted, large trials of hormonal therapy demonstrated the utility of combined...
In a systematic review and meta-analysis reported in Leukemia & Lymphoma, Shah et al identified the risk of cardiotoxicity among patients, most with multiple myeloma, receiving carfilzomib (Kyprolis) in clinical trials. Study Details The study included data from 4,164 patients who received...
In a study reported in the Journal of Oncology Practice, Gannavarapu et al found that substantial unintentional weight loss prior to treatment is common among patients with cancer across stages of disease and is associated with poorer outcome. Study Details The retrospective cohort study included ...
In the international phase III BRIM8 trial reported in The Lancet Oncology, Maio et al found inconclusive evidence of benefit of adjuvant vemurafenib treatment in patients with BRAF V600–mutant melanoma. Study Details In the double-blind trial, 498 patients with fully resected...
An Italian phase III trial (FATA-GIM3) has shown no difference in disease-free survival with 5 years of upfront adjuvant aromatase inhibitor therapy vs 2 years of tamoxifen followed by 3 years of aromatase inhibitor therapy in women with hormone receptor–positive early breast cancer. The...
In a Japanese phase III noninferiority trial reported in the Journal of Clinical Oncology, Ito et al found that dexamethasone could be spared on days 2 and 3 in an antiemetic regimen including the neurokinin-1 (NK1) receptor antagonist aprepitant and palonosetron in patients receiving highly...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies in melanoma. These studies focus on assessing response to checkpoint inhibitors; T-cell immunotherapy; combination therapies; adoptive cell therapy; combination therapy development; and...
On December 5, 2017, bevacizumab (Avastin) was granted regular approval for the treatment of recurrent glioblastoma in adults.1 Bevacizumab was granted accelerated approval in May 2009 for use in treating patients with glioblastoma who had disease progression on prior therapy. Supporting Efficacy...
On March 1, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the anti–connective tissue growth factor (CTGF) antibody pamrevlumab for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the phase II clinical...
In an Indian single-center phase III trial reported in the Journal of Clinical Oncology, Gupta et al found that cisplatin-based chemoradiotherapy improved disease-free survival vs neoadjuvant chemotherapy and radical surgery in women with locally advanced squamous cervical cancer. Study Details...
In a phase III trial reported in The Lancet Oncology, Raje et al found that denosumab was noninferior to zoledronic acid in preventing skeletal-related events (SREs) in newly diagnosed multiple myeloma patients with bone disease. Study Details In the double-blind trial, 1,718 patients with at...
As reported in the Journal of Clinical Oncology by Wapnir et al, the final analysis of the phase III CALOR trial showed benefit of adjuvant chemotherapy in estrogen receptor (ER)–negative but not ER-positive isolated locoregional recurrence of breast cancer. Study Details In this open-label ...
People with stage III colon cancer who regularly eat nuts are at significantly lower risk of cancer recurrence and mortality than those who don’t, according to findings published by Fadelu et al in the Journal of Clinical Oncology. Findings The study followed 826 participants in the CALGB...
As reported in JAMA Oncology by Issels et al, long-term follow-up of the phase III EORTC 62961-ESHO 95 trial has shown improved outcomes with the addition of regional hyperthermia to neoadjuvant chemotherapy in patients with high-risk soft-tissue sarcoma. Study Details In the open-label trial,...
As reported in The Lancet Oncology by de Boer et al, the phase III PORTEC-3 trial has shown no significant improvement in 5-year overall survival with adjuvant chemoradiotherapy vs radiotherapy alone in women with high-risk endometrial cancer. Adjuvant chemoradiotherapy, however, was associated...
In the phase III Hokusai VTE Cancer trial reported by Raskob et al in The New England Journal of Medicine, the direct-acting oral factor Xa inhibitor edoxaban proved noninferior to the low–molecular-weight heparin dalteparin in the composite outcome of recurrent venous thromboembolism or...
As reported by Smith et al in The New England Journal of Medicine, the phase III SPARTAN trial has shown that the androgen receptor inhibitor apalutamide (Erleada) produces significant improvement in metastasis-free survival and time to symptomatic progression vs placebo among men with...