Two Frontline Immunotherapy Combos for NSCLC Hit With Delays
January 24th 2017Two separate delays have been announced by Bristol-Myers Squibb and AstraZeneca in the development of PD-1 and CTLA-4 inhibitor combinations as first-line therapies for patients with advanced or metastatic non–small cell lung cancer.
Encorafenib/Binimetinib a Potential New Treatment Option for BRAF-Mutant Melanoma
January 24th 2017BRAF inhibitor encorafenib combined with the MEK inhibitor binimetinib reduced the risk of progression or death by 46% compared with vemurafenib for patients with <em>BRAF</em>-mutant unresectable melanoma.
Neoadjuvant Nivolumab/Ipilimumab Shows Early Promise for Stage III Melanoma
January 23rd 2017Neoadjuvant therapy with the combination of nivolumab and ipilimumab is plausible and effective, but can induce a high level of adverse events calling for further research into better tolerated dosing schemes.
Study Results Show Nivolumab Improves Survival in Advanced Gastric/GEJ Cancer
January 20th 2017According to findings from the phase III ONO-4538-12 trial, treatment with nivolumab (Opdivo) reduced the risk of death by 37% compared with placebo for patients with advanced gastric or gastroesophageal junction (GEJ) cancer following second or later-line chemotherapy.
Frontline Pembrolizumab Combo Granted Priority Review by FDA for NSCLC
January 11th 2017A supplemental biologics license application for pembrolizumab in combination with pemetrexed plus carboplatin has been granted priority review by the FDA as a treatment for patients with metastatic or advanced non-squamous non–small cell lung cancer without <em>EGFR</em> or <em>ALK</em> mutations and regardless of PD-L1 expression.
PEGPH20 Combo Demonstrates Improved Survival in Pancreatic Cancer
January 10th 2017The combination of PEGPH20 with nab-paclitaxel and gemcitabine demonstrated improvements in progression-free survival compared with nab-paclitaxel/gemcitabine alone for untreated patients with advanced pancreatic cancer.
Pembrolizumab Continues to Show Durable Benefit in Heavily Pretreated TNBC
December 12th 2016Pembrolizumab (Keytruda) continued to show a consistent durable benefit with an additional year of follow-up for heavily pretreated patients with recurrent PD-L1-positive metastatic triple-negative breast cancer.
New Mechanism of Action Prompts Renewed Interest in Eribulin
December 12th 2016There has been renewed interest in eribulin mesylate (Halaven) following its FDA approval for advanced or unresectable liposarcoma and with the introduction of a growing body of preclinical work suggesting the agent has a novel anti–mesenchymal mechanism of action.
Loperamide/Budesonide Combo Prevents Neratinib-Associated Diarrhea for Breast Cancer Patients
December 10th 2016Prophylactic treatment with the combination of loperamide and budesonide reduced the rate of grade ≥3 diarrhea associated with neratinib to 15% compared with 39.9% observed in the ExteNET trial. The rate of all-grade diarrhea was 65% with the prophylactic regimen versus 95.4% in ExteNET, according to findings from the phase II CONTROL trial.
Buparlisib Combo Shows Modest PFS Improvement in Pretreated HR+ Breast Cancer
December 9th 2016Median progression-free survival was improved by 2.1 months with the addition of the pan-PI3K inhibitor buparlisib to fulvestrant for women with HR-positive/HER2-negative advanced breast cancer who received a prior aromatase inhibitor and progressed on or after an mTOR inhibitor.
Higher TILs Levels Associated With OS Improvements in HER2+ Breast Cancer
December 9th 2016Higher levels of tumor-infiltrating lymphocytes (TILs) were associated with improvements in overall survival (OS) for patients with advanced HER2-positive breast cancer treated with docetaxel, trastuzumab (Herceptin), and pertuzumab (Perjeta).
TGR-1202 Combined With Ibrutinib Demonstrates High Response Rate in CLL/MCL
December 9th 2016Combining the PI3 kinase inhibitor TGR-1202 and ibrutinib (Imbruvica) for patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) demonstrated a high response rate without dose-limiting toxicities (DLTs).
Acalabrutinib Produces 38% ORR in Richter Transformation
December 9th 2016The next-generation BTK inhibitor acalabrutinib produced an objective response rate (ORR) of 38.1% as a monotherapy for patents with Richter transformation (RT), according to findings from the phase I/II ACE-CL-001 study presented at the 2016 ASH Annual Meeting.
Hormonal Therapy Improved PFS When Added to Dual HER2-Targeted Therapy
December 9th 2016The addition of an aromatase inhibitor (AI) to pertuzumab (Perjeta) and trastuzumab (Herceptin) improved progression-free survival (PFS) by 3.09 months, when compared with trastuzumab plus an AI, according to findings from the phase II PERTAIN trial.
Atezolizumab/Cobimetinib Combination Demonstrates High Response Rate in Advanced Melanoma
December 8th 2016The addition of the PD-L1 inhibitor atezolizumab (Tecentriq) to the MEK inhibitor cobimetinib (Cotellic) and the BRAF inhibitor vemurafenib (Zelboraf) induced a high response rate for patients with <em>BRAF</em>-mutant unresectable melanoma.
KTE-C19 Treatment Shows Impressive Responses in Aggressive Lymphomas
December 6th 2016Treatment with the CD19-directed CAR T-cell therapy KTE-C19 showed a complete remission rate of 73% for patients with aggressive, chemorefractory primary mediastinal B-cell lymphoma and transformed follicular lymphoma, according to findings from the multicenter phase II ZUMA-1 study.
Enasidenib Treatment Active in Pretreated Patients With IDH2-Mutant MDS
December 6th 2016Treatment with enasidenib (AG221) was active and was well tolerated in pretreated patients with IDH2-mutated myelodysplastic syndrome, including those who failed hypomethylating agents, according to findings from a phase I/II study.
Pembrolizumab Triplet Induces Durable Responses for Multiple Myeloma
December 5th 2016Pembrolizumab (Keytruda), pomalidomide (Pomalyst), and dexamethasone had an objective response rate of 65% and a very good partial response or better rate of 29% for patients with relapsed/refractory multiple myeloma, according to phase II findings presented at the 2016 ASH Annual Meeting.
Nivolumab/Ibrutinib Combo Shows Encouraging Activity for Richter Transformation
December 4th 2016Treatment with the combination of nivolumab (Opdivo) and ibrutinib (Imbruvica) showed encouraging activity and safety in a small phase II study of patients with chronic lymphocytic leukemia and Richter transformation.
New BRAF/MEK Combo Highly Effective in Phase III Melanoma Study
November 15th 2016Treatment with the BRAF inhibitor encorafenib combined with the MEK inhibitor binimetinib improved median progression-free survival by 7.6 months compared with monotherapy with vemurafenib for patients with <em>BRAF</em>-mutant unresectable melanoma.
PD-1/CTLA-4 Inhibitor Combination Highly Effective for Metastatic Bladder Cancer
November 15th 2016Treatment with the combination of nivolumab and ipilimumab at selected doses led to a high response rate and marked improvements in overall survival for patients with pretreated metastatic urothelial carcinoma.
Nivolumab Improves Survival in Advanced Gastric Cancer
November 11th 2016The PD-1 inhibitor nivolumab extended overall survival versus placebo for patients who were refractory or intolerant to standard therapy with unresectable, advanced, or recurrent gastric cancer, according to topline data from the phase III ONO-4538-12 trial.