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Addressing Loss of Response to Ruxolitinib in Myelofibrosis
October 31st 2018Robyn M. Scherber, MD, MPH, discusses the prevalence of ruxolitinib failure and how it can be managed in patients with MF. She also highlights combinations and other treatment regimens currently under investigation for this patient population.
Exploring Response and Resistance to Checkpoint Inhibitor Therapy in Bladder, Other GU Cancers
October 29th 2018Padmanee Sharma, MD, PhD, discusses the development of checkpoint inhibitors in several cancers, including urothelial carcinoma, RCC, and prostate cancer. She also addresses the challenges in resistance to these agents and where some clinical trials are moving forward in the field.
Promising Antitumor Activity Seen With Pembrolizumab in NMIBC
October 29th 2018According to results from an interim analysis of an ongoing single-arm open-label phase II study, pembrolizumab demonstrated promising antitumor activity in patients with high-risk nonmuscle invasive bladder cancer that are unresponsive to Bacillus Calmette-Guérin and refused or were ineligible for cystectomy.
Ruxolitinib Granted Priority Review by FDA for GVHD
October 27th 2018Based on data from the phase II REACH1 trial, a supplemental new drug application for ruxolitinib has been granted a priority review designation by the FDA for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids. The designation was announced by Incyte, the manufacturer of the JAK1/JAK2 inhibitor.
Expert Highlights Efficacy of Avelumab in Early Lines of Therapy for Advanced RCC
October 26th 2018Ulka Vaishampayan, MD, discussed the data reported from the phase Ib JAVELIN Solid Tumor trial at the ESMO 2018 Congress and addressed how these data will affect the treatment landscape for patients with advanced RCC.
Rini Highlights Benefit With Atezolizumab/Bevacizumab Combo in Distinct Gene Signatures in RCC
October 26th 2018In an interview with <em>Targeted Oncology, </em>Brian I. Rini, MD, discussed these core findings from the IMmotion 151 trial he presented at the conference, as well as the implications of these findings in RCC moving forward.
TAS-102 Granted Priority Review by FDA for Gastric/GEJ Cancer
October 26th 2018Based on data from the phase III TAGS trial, a supplemental new drug application seeking approval for TAS-102 (trifluridine/tipiracil; Lonsurf) for use in previously treated patients with advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction, has been granted a priority review by the FDA.
Higher Dose of Ipilimumab Plus Nivolumab Demonstrates Benefit in Bladder Cancer
October 25th 2018The treatment regimen of nivolumab (Opdivo) at 1 mg/kg plus ipilimumab at (Yervoy) 3 mg/kg induced higher overall response rates and longer progression-free survival in patients with platinum-pretreated metastatic urothelial carcinoma, according to extended follow-up data reported at the 2018 ESMO Annual Congress.<br />
QUADRA Data Support Use of Niraparib in Later Lines of Therapy for Relapsed Ovarian Cancer
October 25th 2018Data from a posthoc analysis of the phase II QUADRA trial support the use of niraparib in later lines of therapy in patients with relapsed ovarian cancer who have <em>BRCA</em> mutations, said Kathleen N. Moore, lead investigator of the trial. According to findings reported at the 2018 ESMO Annual Congress, when used in the fourth line or later, niraparib exhibited an overall response rate of approximately 30% in this subset of patients.
New Regimens Lead to More Personalized Approach in Hodgkin Lymphoma, MCL
October 24th 2018The treatment landscapes of Hodgkin lymphoma and mantle cell lymphoma have progressed to a more personalized therapeutic approach in clinical practice due to the introduction of the latest novel regimens, according to Chaitra S. Ujjani, MD.
Pegylated Doxorubicin Added to Bevacizumab and Carboplatin Extends PFS in Recurrent Ovarian Cancer
October 24th 2018As an add-on to bevacizumab, carboplatin plus pegylated liposomal doxorubicin significantly extended progression-free survival compared with carboplatin and gemcitabine in patients with recurrent ovarian cancer whose first disease recurrence was >6 months after first-line platinum-based chemotherapy.
Promising Survival Improvement With Trifluridine/Tipiracil in Heavily Pretreated Gastric/GEJ Cancer
October 24th 2018According to a presentation at the 2018 ESMO Congress, risk of death was reduced with trifluridine/tipiracil versus placebo in patients with heavily pretreated gastric or gastroesophageal junction cancer. Lead TAGS trial author Hendrik-Tobias Arkenau, MD, PhD, said there was also improvement in progression-free survival and disease control.
FDA Adds 3 Months to Review Period for Nivolumab Plus Ipilimumab for TMB-High NSCLC
October 23rd 2018Three months have been added on by the FDA to the review period for the supplemental biologics license application for the frontline treatment combination of nivolumab plus low-dose ipilimumab for patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
Follow-Up Data Confirm RFS Benefit With Dabrafenib/Trametinib Combo in BRAF+ Melanoma
October 23rd 2018In long-term follow-up results from the COMBI-AD trial, the relapse-free survival benefit with adjuvant dabrafenib (Tafinlar) and trametinib (Mekinist) was confirmed in patients with resected stage III <em>BRAF</em>-mutant melanoma. The follow-up data were reported by Georgina Long, MBBS, PhD, during the 2018 ESMO Congress in Munich, Germany.
Frontline Pembrolizumab/Axitinib Combo Demonstrates Survival Benefit in RCC
October 19th 2018Patients with advanced or metastatic renal cell carcinoma who were treated with the combination of pembrolizumab (Keytruda) and axitinib (Inlyta) demonstrated a significantly improved survival benefit compared with sunitinib (Sutent) in the first-line setting, meeting the endpoints of the pivotal phase III KEYNOTE-426 trial.
Ibrutinib and Obinutuzumab Combo Granted Priority Review by FDA For Frontline CLL
October 17th 2018A supplemental new drug application for ibrutinib (Imbruvica) has been granted a priority review by the FDA for use in combination with obinutuzumab (Gazyva) as a frontline treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Burstein Examines Predictive Value in Genomic Tests for Breast Cancer
October 17th 2018Genomic assays and signatures are increasingly being used as a prognostic indicator for guiding treatment decisions, according to Harold J. Burstein, MD, PhD. During a presentation at the 2018 Lynn Sage Breast Cancer Symposium in Chicago, he explained that many of these tests can also be used as predictive indicators.
Olaparib Granted Orphan Drug Designation by FDA for Pancreatic Cancer
October 17th 2018Olaparib (Lynparza) has been granted an orphan drug designation by the FDA for the treatment of patients with pancreatic cancer, AstraZeneca and Merck, the developers of the PARP inhibitor, have announced.
Talazoparib Receives FDA Approval in BRCA-Mutated, HER2-Negative Breast Cancer
October 16th 2018Talazoparib has been approved by the FDA for treatment of patients with deleterious or suspected deleterious germline <em>BRCA</em>-mutated, HER2-negative locally advanced or metastatic breast cancer, according to Pfizer, the manufacturer of the PARP inhibitor.
Benefit From Adjuvant Chemotherapy Seen in Younger Women With Breast Cancer
October 16th 2018Although, it is challenging to determine the optimal adjuvant therapy for younger patients with breast cancer, Mark Robson, MD, encouraged that the addition of adjuvant chemotherapy does show a benefit in this patient population.
Use of Tumor-Infiltrating Lymphocytes Expanding in Breast Cancer
October 16th 2018The role of tumor-infiltrating lymphocytes (TILs) is expanding in cancer care, necessitating a more involved role for pathologists to quantify immune infiltrates, K.P. Siziopikou, MD, PhD, suggested during a presentation at the 2018 Lynn Sage Breast Cancer Symposium.
Overall Survival Not Improved With Nivolumab in SCLC
October 15th 2018According to topline findings, the phase III CheckMate-331 trial of nivolumab monotherapy for patients with small cell lung cancer who relapsed following platinum-based chemotherapy failed to meet its primary endpoint of improved overall survival compared with the standard topotecan or amrubicin.
Analyzing the Role of Molecular Profiling in Patients With Metastatic Breast Cancer
October 15th 2018Patients with HER2-positive, microsatellite instability-high (MSI-H), and <em>NTRK</em> gene fusion-positive breast cancer likely benefit more than others from molecular profiling. In a presentation at the 2018 Lynn Sage Breast Cancer Symposium in Chicago, Illinois, Sledge discussed the growing use of molecular profiling, especially for metastatic cancers, as well said the decreasing cost of sequencing.
LOXO-292 Granted FDA's Breakthrough Designation for RET Fusion-Positive Thyroid Cancer
October 15th 2018LOXO-292 has been granted a breakthrough therapy designation by the FDA for treatment of patients with advanced RET fusion–positive thyroid cancer requiring systemic therapy, who have progressed on prior treatment and have no other acceptable alternative treatment options. Loxo Oncology, the developer of the selective RET inhibitor, released the news of the designation in a statement today.
Independent Review Supports Positive Findings With Frontline Lenvatinib in HCC
October 13th 2018An independent assessment conducted as part of the pivotal, international phase III REFLECT trial confirmed positive responses demonstrated by lenvatinib (Lenvima) as a first-line therapy for patients with HCC.