Regorafenib Dose-Escalation Strategy Superior to Standard Dosing in mCRC
July 6th 2018A strategy of escalating regorafenib from 80 mg to 160 mg per day was superior to starting at a dose of 160 mg per day in patients with refractory metastatic colorectal cancer, according to results from the regorafenib dose optimization study presented at the 2018 World Congress on GI.
Atezolizumab Fails to Demonstrate Superior Survival Over Regorafenib in mCRC
July 5th 2018According to findings from the IMblaze370 study, atezolizumab alone or in combination with cobimetinib did not demonstrate superior overall survival when compared with regorafenib for the treatment of patients with chemorefractory metastatic colorectal cancer. Findings from the study were presented at the 2018 World Congress on Gastrointestinal Cancer.
Sustained Survival Rates Seen With Oncolytic Poliovirus in Patients With Recurrent GBM
June 26th 2018According to phase I findings recently published in the<em> New England Journal of Medicine, </em><sup> </sup>the recombinant oncolytic poliovirus PVSRIPO demonstrated a 2- and 3-year overall survival (OS) rate of 21% (95% CI, 11%-33%) for patients with recurrent grade IV malignant glioblastoma.
OS Endpoint Not Met With Palbociclib in PALOMA-3 Breast Cancer Study
June 26th 2018Overall survival was not improved with the combination of palbociclib and fulvestrant compared with fulvestrant and placebo in the phase III PALOMA-3 trial for patients with HR-positive, HER2-negative metastatic breast cancer who received prior endocrine therapy, according to Pfizer, the developer of the CDK4/6 inhibitor.
Osimertinib Granted European Approval for Frontline Treatment of EGFR-mutant NSCLC
June 12th 2018Osimertinib (Tagrisso) has been approved by The European Commission as a frontline treatment for patients with <em>EGFR</em>-mutant locally-advanced or metastatic non–small cell lung cancer. The approval is based on data from the phase III FLAURA trial.
Overall Survival Increased in NSCLC With First-Line Atezolizumab Combination
June 5th 2018Overall survival improved with the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel versus a treatment regimen of bevacizumab and chemotherapy alone in patients with advanced wild-type nonsquamous non–small cell lung cancer.
Durable Remissions With Liso-Cel in High-Risk DLBCL in Updated Findings from TRANSCEND Study
June 4th 2018Durable complete remissions were seen in 46% of patients with high-risk diffuse large B-cell lymphoma treated with the CAR T-cell therapy lisocabtagene maraleucel at 6 months. These results come from the updated findings from the phase I, multicenter TRANSCEND trial that were presented at the 2018 ASCO Annual Meeting.
Rituximab Plus Lenalidomide Shows Promise in First-Line Setting for Follicular Lymphoma
June 4th 2018Based on data reported at the 2018 ASCO Annual Meeting, the primary endpoint of the phase III RELEVANCE trial was not met with the combination of rituximab plus lenalidomide showing similar efficacy results compared with rituximab plus chemotherapy in treatment-naive patients with follicular lymphoma. The chemotherapy-free regimen, however, did show a more favorable toxicity profile.
High MRD-Negative Responses Achieved With Upfront Ibrutinib/Venetoclax for CLL
June 4th 2018Treatment-naive patients with chronic lymphocytic leukemia achieved high rates of minimal residual disease–negative status of 77% with peripheral blood testing after 6 cycles from treatment with ibrutinib (Imbruvica) and venetoclax (Venclexta). Additionally, patients in the CAPTIVATE trial, wihch was presented during the 2018 ASCO Annual Meeting, achieved an objective response rate of 100%.
Patients With t(11;14) Myeloma Show Improved Outcomes With Added Venetoclax
June 3rd 2018Patients with relapsed/refractory t(11;14) multiple myeloma achieved high rates of responses when venetoclax was added to the combination of carfilzomib and dexamethasone, according to findings from an ongoing phase II study presented during the 2018 ASCO Annual Meeting.
LOXO-292 Induces 77% ORR in RET-Positive Tumors
June 2nd 2018The highly-selective RET inhibitor LOXO-292 induced an objective response rate of 77% for patients with RET fusion-positive non–small cell lung cancer, according to findings from the phase I LIBRETTO-001 study presented at the 2018 ASCO Annual Meeting.
Strong PFS Seen With bb2121 in Heavily Pretreated Multiple Myeloma
June 2nd 2018In updated findings from the multicenter phase I CRB-401 study that were presented at the 2018 ASCO Annual Meeting, the anti-BCMA CAR T-cell therapy bb2121 induced a median progression-free survival of 11.8 months and a median duration of response of 10.8 months for patients with relapsed/refractory heavily pretreated multiple myeloma.
FDA Extends Review Period for Lenvatinib in Hepatocellular Carcinoma
June 1st 2018The review period for lenvatinib as a first-line treatment for patients with unresectable hepatocellular carcinoma has been extended by the FDA. According to Eisai and Merck, the companies codeveloping the drug, this will allow ample time to review the application.
FDA Accepts Application for Cabozantinib in Advanced HCC
May 30th 2018A supplemental new drug application seeking the approval of cabozantinib for the treatment of patients with previously-treated advanced hepatocellular carcinoma has been accepted by the FDA, according to a statement from Exelixis, the company developing the agent.
Two Studies Investigating Daratumumab/Checkpoint Inhibitor Combos in NSCLC, Myeloma Terminated
May 30th 2018Following a planned interim analysis, 2 early-phase clinical trials exploring daratumumab in combination with either a PD-1 inhibitor for multiple myeloma or a PD-L1 inhibitor for non–small cell lung cancer have been terminated, according to a statement from Genmab, the company codeveloping daratumumab with Janssen.
New Abiraterone Acetate Formulation Approved by FDA for mCRPC
May 25th 2018A new formulation of abiraterone acetate in combination with methylprednisolone has been approved by the FDA as a treatment for men with metastatic castration-resistant prostate cancer, according to Sun Pharma, the company commercializing the treatment.
Shorter Duration of Trastuzumab Noninferior to Standard 12 Months in Early HER2+ Breast Cancer
May 17th 2018In patients with HER2-positive early breast cancer, 6 months of adjuvant treatment with trastuzumab (Herceptin) was noninferior for disease-free survival compared with the standard 12-month schedule, according to findings from the phase III PERSEPHONE trial presented ahead of the 2018 ASCO Annual Meeting.
Additional Analyses Show Consistent Benefit With Regorafenib in HCC
May 9th 2018According to additional analyses from the phase III RESORCE trial published in the<em> Journal of Hepatology, s</em>econd-line regorafenib continued to show antitumor activity regardless of prior dose or time to progression on frontline sorafenib (Nexavar) for patients with unresectable advanced hepatocellular carcinoma.
Daratumumab/VMP Receives FDA Approval in Frontline Setting for Multiple Myeloma
May 8th 2018Daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone received FDA approval as a frontline regimen for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Updated Findings Confirm Nivolumab OS Benefit in SCCHN
April 18th 2018Patients with metastatic or recurrent squamous cell carcinoma of the head and neck experienced a 32% reduction in the risk of death compared with investigator's choice of therapy, according to updated findings with a minimum of 2 years of follow-up from the phase III CheckMate-141 study.
Fostamatinib Approved by FDA for Chronic ITP in the Second-Line Setting
April 18th 2018After findings from 2 randomized trials and an open-label extenstion study were released, fostamatinib (Tavalisse), anSYK inhibitor, was approved by the FDA as a second-line treatment following insufficient response to a previous therapy for patients with chronic immune thrombocytopenia.
Crizotinib Reaches 100% Disease Control Rate in ALK+ Inflammatory Myofibroblastic Tumors
April 16th 2018In a precision medicine success story, crizotinib (Xalkori) demonstrated a 50% objective response rate and a 100% disease control rate in patients with <em>ALK</em>-positive advanced, inoperable inflammatory tumors, in findings from the CREATE study presented at the 2018 AACR Annual Meeting.
Expert Reviews Efficacy, Safety Data with Abemaciclib in Breast Cancer
March 13th 2018Abemaciclib, the only CDK4/6 inhibitor approved as a single-agent, has amassed several clinical indications for patients with metastatic breast cancer. The findings from the phase III MONARCH2 and 3 trials, as well as the phase II MONARCH1 study led to these approvals. Each trial showed improvements in progression-free survival, especially in patients with visceral disease and endocrine therapy resistance.
Study Confirms Olaparib Benefit in Advanced Breast Cancer
March 12th 2018Presented at the 2018 Miami Breast Cancer Conference, results from the phase III OlympiAD trial demonstrated improvements in progression-free survival with olaparib over treatment of physician's choice. These results were consistent regardless of the baseline tumor burden for patients with HER2-negative breast cancer with a germline <em>BRCA</em>1/2 mutation.
Ivosidenib Granted Priority Review Designation by FDA for IDH1+ AML
February 15th 2018Based on findings from a phase I trial presented at the 2017 ASH Annual Meeting, ivosidenib (AG-120) has been granted a priority review designation by the FDA for the treatment of patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia.
Enzalutamide Reduces Risk of Death by 71% With ADT in CRPC
February 9th 2018In findings from the phase III PROSPER trial released ahead of the 2018 Genitourinary Cancers Symposium, the enzalutamide (Xtandi) and androgen deprivation therapy (ADT) combination reduced the risk of metastases or death by 71% compared with ADT alone for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC).
PFS Improvement With Atezolizumab Combination in Metastatic Renal Cell Carcinoma
February 8th 2018As stated in findings from IMmotion151, a phase III open-label study, the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) induced a 26% reduction in the risk of progression or death compared with sunitinib (Sutent) for patients with untreated PD-L1–positive metastatic renal cell carcinoma. This study was released ahead of the 2018 Genitourinary Cancers Symposium.