The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Ivosidenib Induces OS Benefit in Advanced IDH1+ Cholangiocarcinoma
January 17th 2021January 17, 2021 — Ivosidenib tablets led to a 21% reduction in the risk of death compared with placebo in previously treated patients with IDH1-mutant cholangiocarcinoma, according to the final overall survival analysis of the phase 3 ClarIDHy trial.
TAS-102 Plus Bevacizumab Improves OS in mCRC Ineligible for Intensive Therapy
January 17th 2021January 16, 2021 - Trifluridine/tipiracil, when used in combination with bevacizumab, led to an improvement in overall survival over capecitabine/bevacizumab in the frontline treatment of patients with unresectable metastatic colorectal cancer who are not eligible for standard chemotherapy.
Addition of Pembrolizumab to Chemo Does Not Negatively Impact QoL in Patients With Esophageal Cancer
January 16th 2021January 16, 2021 - Health-related quality of life during an 18-week period proved to be similar over for patients with esophageal cancer treated with either pembrolizumab or placebo added to chemotherapy.
Frontline Pembrolizumab Improves PFS2, HRQoL in MSI-H/dMMR mCRC
January 16th 2021January 16, 2021 - Frontline use of pembrolizumab monotherapy significantly improved progression-free survival, while demonstrating superior safety, compared with chemotherapy in patients with microsatellite-instability high/mismatch repair deficient metastatic colorectal cancer.
Frontline Bemarituzumab/mFOLFOX6 Combo Improves Survival in Advanced FGFR2b+ Gastric/GEJ Cancer
January 16th 2021Bemarituzumab combined with mFOLFOX6 demonstrated a 56% reduction in the risk of disease progression or death compared with placebo and mFOLFOX6 as a frontline treatment in select patients with FGFR2b-positive advanced gastric or gastroesophageal junction adenocarcinoma.
Lenvatinib and Pembrolizumab Combination Safe, Effective For Multiple Gastrointestinal Cancer Types
January 15th 2021The combination of the anti-angiogenic multikinase inhibitor lenvatinib plus the anti-PD-1 antibody pembrolizumab demonstrated promising antitumor activity and a manageable safety profile in previously treated patients with advanced gastric cancer, advanced metastatic microsatellite instability-high or mismatch repair colorectal cancer, and advanced biliary tract cancers
FDA Approves Trastuzumab Deruxtecan for HER2+ Metastatic Gastric/GEJ Cancer
January 15th 2021January 15, 2021- The FDA has approved fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a previous trastuzumab-based regimen.
FDA Approves Subcutaneous Daratumumab Plus VCd for Newly Diagnosed Light-Chain Amyloidosis
January 15th 2021January 15, 2021 - The FDA has approved daratumumab and hyaluronidase-fihj, a subcutaneous formulation of daratumumab, for use in combination with bortezomib, cyclophosphamide, and dexamethasone in the treatment of patients with newly diagnosed light-chain amyloidosis.
Anlotinib Induces PFS Benefit in RAS/BRAF Wildtype+ mCRC
January 15th 2021January 15, 2021 - Anlotinib, a multitarget kinase inhibitor, was found to significantly improve progression-free survival with a manageable safety profile when used in Chinese patients with refractory metastatic colorectal cancer.
Liposomal Irinotecan Plus 5-FU Shows Real-World OS Benefit in Metastatic PDAC
January 15th 2021January 15, 2021 - One-year overall survival was found increased the longer that patients with metastatic pancreatic ductal adenocarcinoma remained on treatment with liposomal irinotecan plus 5-fluorouracil/leucovorin.
Nivolumab Improves Quality of Life in Patients with Esophageal/Gastroesophageal Cancer
January 15th 2021January 15, 2021 - Patients with esophageal/gastroesophageal cancer treated with nivolumab had improved esophageal-specific and general quality of life, although trends were similar in those treated with placebo.
Camrelizumab/Apatinib Shows Promising Activity in Second-Line Esophageal Squamous Cell Carcinoma
January 15th 2021January 15, 2021 - A novel combination comprised of camrelizumab and apatinib was found to have promising clinical efficacy with an acceptable safety profile when used as a second-line treatment in patients with esophageal squamous cell carcinoma.
Fixed-Dose Durvalumab Approved in Europe for Unresectable NSCLC
January 15th 2021January 15, 2021 - Durvalumab has been approved in the European Union and the United Kingdom for a fixed-dose option of 1,500 mg every 4 weeks for use in patients with locally advanced, unresectable non–small cell lung cancer whose tumors have a PD-L1 expression of at least 1% and who have not experienced disease progression after platinum-based chemoradiation treatment.
Pembrolizumab Plus Capecitabine/Bevacizumab Shows Favorable Tolerability in MSS mCRC
January 15th 2021January 15, 2021 - Pembrolizumab (Keytruda) in combination with capecitabine and bevacizumab (Avastin) was found to show encouraging tolerability when used in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC), according to data from a phase 2 trial (NCT03396926) presented during the 2020 Gastrointestinal Cancers Symposium.
More Than 2 Cycles of Cisplatin Significantly Reduces Risk of Second Testicular Cancer
January 15th 2021January 15, 2021 - The risk of a second metachronous contralateral germ cell testicular cancer is found to be significantly reduced with each additional cycle of cisplatin-based chemotherapy in patients.
FDA Approves Crizotinib for Pediatric and Young Adult ALK+ Anaplastic Large Cell Lymphoma
January 14th 2021January 14, 2021 - The FDA has approved crizotinib for the treatment of pediatric patients 1 year of age and older and young adults with ALK-positive relapsed or refractory, systemic anaplastic large cell lymphoma.
Sintilimab Injection Second-Line Squamous NSCLC Application Accepted in China
January 14th 2021January 14, 2020 — The National Medical Products Administration of China has accepted a supplemental new drug application for sintilimab injection for use in the second-line treatment of patients with squamous non–small cell lung cancer.
Frontline Tislelizumab/Chemo Approved in China for Advanced Squamous NSCLC
January 14th 2021January 14, 2020 - The China National Medical Products Administration has approved tislelizumab for use in combination with 2 chemotherapy regimens in the frontline treatment of patients with advanced squamous non–small cell lung cancer.