Repotrectinib Shows Promising Interim Results in ROS1+ and NTRK+ Tumors, FDA Responds to Data
August 19th 2020Objective response rates for repotrectinib in patients with ROS1-positive non–small cell lung cancer and NTRK fusion-positive advanced solid tumors are encouraging, according to interim data from the phase 2 TRIDENT-1 clinical trial.
Frontline Ilixadencel Plus Sunitinib Demonstrates Further Survival Benefit in mRCC
August 19th 2020Frontline ilixadencel in combination with sunitinib as utilized in newly diagnosed patients with metastatic renal cell carcinoma in the phase 2 MERECA clinical trial has updated survival data, which indicates continued survival benefit with the combination over sunitinib alone.
COVID-19 Severity in CLL Correlates With 3 Disease Characteristics
August 18th 2020The severity of coronavirus disease 2019 increases with age in patients with chronic lymphocytic leukemia. However, age and the existence of comorbidities may not impact death from COVID-19, according to results from a retrospective international study.
FDA Grants Priority Review to Fixed-Dose Durvalumab in NSCLC and Bladder Cancer
August 18th 2020The FDA has accepted a Biologics License Application for a new 4-week fixed-dose regimen containing durvalumab and granted it Priority Review for the approved indications of non–small cell lung cancer, as well as bladder cancer.
Modern Therapies Offer a Way to Reach the Brain in HER2+ Metastatic Breast Cancer
August 14th 2020In an interview with Targeted Oncology, Stephanie Weiss, MD, reviewed the treatment landscape for HER2-positive metastatic breast cancer and gave her predictions on how the paradigm will evolve for patients with brain metastases now that tucatinib has demonstrated efficacy.
Pazopanib Activity in RAI-Refractory Differentiated Thyroid Cancer Corroborated in Prospective Study
August 14th 2020Pazopanib was confirmed active with manageable toxicities as treatment of patients with progressive radioactive-iodine–refractory differentiated thyroid cancer, based on results of a prospective study.
HER2CLIMB Regimen Delays CNS Progression in HER2+ Metastatic Breast Cancer
August 14th 2020In an interview with Targeted Oncology following the SNO Brain Metastasis Meeting, Nancy Lin, MD, discussed the treatment of brain metastases in HER2-positive metastatic breast cancer in general, as well as the subgroup analysis of patients with brain metastases in the phase 2 HER2CLIMB clinical trial.
Lenvatinib Starting Dose Confirmed for Refractory RAI-Refractory DTC Indication
August 11th 2020A phase 2 clinical trial of radioactive iodine–refractory differentiated thyroid cancer demonstrated that the lenvatinib starting dose of 24 mg is superior to the lower dose of 18 mg, missing the noninferiority primary end point of the study.
Nivolumab/Ipilimumab Improves Survival Outcomes in Metastatic Gastric/GEJ Cancers
August 11th 2020Overall survival and progression-free survival were improved with nivolumab plus ipilimumab and chemotherapy compared with chemotherapy alone as frontline treatment of patients with metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.
FDA Issues Complete Response Letter Regarding NDA for Pedmark in Cisplatin-Induced Ototoxicity
August 11th 2020The FDA issued a complete response letter to Fennec Pharmaceuticals Inc, developer of a sodium thiosulfate formulation, Pedmark, which is intended for the treatment of patients aged 18 years or younger with localized, non-metastatic solid tumors, as prevention of cisplatin-induced ototoxicity.
Afatinib Followed by Osimertinib Achieves Nearly 4-Year OS in EGFR T790M+ Non–Small Cell Lung Cancer
August 10th 2020Sequential afatinib followed by osimertinib led to a median overall survival of 47.6 months in patients with EGFR T790M–positive non–small cell lung cancer, according to results from the real-world study, GioTag.
Nivolumab/Ipilimumab Improves OS in Unresectable Malignant Pleural Mesothelioma
August 10th 2020Nivolumab in combination with ipilimumab significantly improved overall survival (OS) in treatment-naïve patients with unresectable malignant pleural mesothelioma (MPM) who were treated in the phase 3 CheckMate 743 clinical trial.
CS1001 Plus Chemotherapy Prolongs Progression-Free Survival in Stage IV NSCLC
August 7th 2020The combination of CS1001 and chemotherapy led to an improvement in progression-free survival among patients with stage IV squamous and non-squamous non–small cell lung cancer, according to data from the phase 3 CS1001-302 clinical trial assessed by an Independent Data Monitoring Committee, achieving the study’s primary end point.
Omburtamab BLA Submitted for FDA Approval in CNS/Leptomeningeal Metastasis From Neuroblastoma
August 6th 2020A completed Biologics License Application was submitted to the FDA for omburtamab, an investigation monoclonal antibody, which is intended for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.
MMRF CureCloud Study Launches to Democratize Access to Genomic Data in Multiple Myeloma
August 5th 2020In an interview with Targeted Oncology, Hearn Jay Cho, MD, PhD, and Irene M. Ghobrial, MD, both discussed the importance of the CureCloud study for the multiple myeloma community, and their hopes for what this study can achieve for myeloma patients and their physicians.
Lorlatinib Prolongs PFS Over Crizotinib in ALK+ NSCLC, Adds to Existing Data for FDA Submission
August 5th 2020Lorlatinib demonstrated an improvement in progression-free survival compared with crizotinib as treatment of patients with treatment-naïve advanced ALK-positive non–small cell lung cancer, meeting the primary end point of the phase 3 CROWN trial.
Lenalidomide/Rituximab Induction as Effective as Rituximab Plus Chemo in Follicular Lymphoma Subset
August 4th 2020Lenalidomide in combination with rituximab (Rituxan, R2) induction has the ability to achieve high rates of complete molecular response (CMR), similar to rituximab plus chemotherapy, when used as frontline therapy in patients with follicular lymphoma (FL), according to results from the phase 3 RELEVANCE trial (NCT01650701).
Tisagenlecleucel Demonstrates Favorable Complete Response Rate, Meets Phase II Primary End Point
August 4th 2020Tisagenlecleucel, a chimeric antigen receptor T-cell therapy, showed evidence of clinical benefit for patients with relapsed or refractory follicular lymphoma, in terms of complete response rate, meeting the primary end point of the phase 2 ELARA clinical trial.
FDA Approval Being Considered for Neoadjuvant/Adjuvant Pembrolizumab +/- Chemo in Early TNBC
July 30th 2020The FDA has accepted a supplemental Biologics License Application submitted for neoadjuvant pembrolizumab combined with chemotherapy and adjuvant pembrolizumab monotherapy for the treatment of patients with high-risk early-stage triple-negative breast cancer.
Pembrolizumab Plus Chemotherapy on the Road to FDA Approval for mTNBC, Granted Priority Review
July 30th 2020The FDA accepted a supplemental Biologics License Application for and granted Priority Review to pembrolizumab in combination with chemotherapy, which is intended for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1.
FDA Grants Breakthrough Therapy Designation to Osimertinib in EGFR+ Lung Cancer
July 30th 2020The FDA granted Breakthrough Therapy designation to osimertinib as adjuvant treatment of patients with stage IB-IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.
Pembrolizumab Plus Nab-Paclitaxel May Be an Option for Switch Maintenance Following Chemo in mUC
July 29th 2020The combination of pembrolizumab plus nab-paclitaxel demonstrated clinically meaningful and sustainable responses, along with prolonged progression-free survival when administered as salvage therapy to patients with metastatic urothelial carcinoma.