April 2016PDF

 

Head and Neck Cancers

Opdivo Extends OS in Phase III Squamous Cell Carcinoma Trial

A phase III trial of PD-1 inhibitor Opdivo showed significant survival benefit at one year—compared to investigator’s choice of methotrexate, docetaxel or cetuximab—in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death, with a median overall survival of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for investigator’s choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101).

The one-year survival rate for Opdivo was 36 percent compared to 16.6 percent for investigator’s choice. The safety profile of Opdivo in CheckMate-141 was consistent with prior studies, with no new safety signals identified.

     

    Melanoma

    Opdivo-Yervoy Combination Demonstrates Two-Year Survival Rate of 69 Percent

    Overall survival data from CheckMate-069, a phase II trial of a Opdivo and Yervoy combination regimen in patients with previously untreated advanced melanoma, demonstrated a two-year overall survival rate of 69 percent compared to 53 percent for Yervoy alone (HR=0.58 [95% CI: 0.31-1.08]) in patients with BRAF wild-type advanced melanoma.

    CheckMate-069 evaluated 142 patients with previously untreated unresectable or metastatic melanoma who received either the Opdivo and Yervoy combination regimen (n=95) or Yervoy alone (n=47). The trial included patients with BRAF wild-type and BRAF V600 mutation-positive melanoma, and randomization was stratified by BRAF mutation status.

       

      Drugs and Targets

      FDA Grants Accelerated Approval To Venclexta Tablets in CLL

      FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

      The indication was approved based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

      Also:

         

        Ovarian Cancer

         

        Prostate Cancer

        Study: SBRT Delivers 98.6% Cure Rate at Five-Year Followup

         

        Soft Tissue Sarcoma

        Researchers: Radiation After Surgery Benefits Older Patients More than Younger Patients

         

        NCI CTEP-Approved Trials for the Month of April

         

        Letter to the Editor

        GOG Foundation Sends Rebuttal Letter to Oncolytics Biotech

        May 2016
        March 2016PDF

         

         

        Leukemia

        Vyxeos Injection Improves Overall Survival In Phase III Acute Myeloid Leukemia Trial

        A phase III trial of Vyxeos Liposome for Injection demonstrated statistically significant improvements in overall survival in patients with high-risk secondary acute myeloid leukemia.

        The median overall survival for patients treated with Vyxeos (cytarabine: daunorubicin) in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3.

        The hazard ratio was 0.69 (p=0.005) which represents a 31 percent reduction in the risk of death versus 7+3, according to Celator Pharmaceuticals Inc., the drug’s sponsor, which plans to submit the data for presentation at the 2016 annual meeting of the American Society of Clinical Oncology.

         Non-Small Cell Lung Cancer

        Atezolizumab Immunotherapy Boosts OS Compared to Docetaxel in Phase II Trial

        Patients with advanced metastatic lung cancer treated with atezolizumab, a targeted immunotherapy drug, lived significantly longer and with fewer side effects than those who received docetaxel chemotherapy, according to a study published in The Lancet.

        “The results of this study demonstrate that the use of atezolizumab, a monoclonal antibody, improves the survival rate of a majority of lung cancer patients who have progressive cancer when used after first-line chemotherapy,”

        Also:

         Drugs and Targets

        FDA Approves Imbruvica in First-Line CLL

        FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia.

        The approval is based on data from the randomized, multi-center, open-label phase III RESONATE-2 trial, which evaluated the use of Imbruvica versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma aged 65 years or older. The data were previously presented at the annual meeting of the American Society of Hematology in December 2015 and also published in The New England Journal of Medicine.

        Also:

        Ovarian Cancer

        Study: Reolysin-Paclitaxel Combination Demonstrates Higher Response Than Paclitaxel Therapy Alone

         Glioblastoma

        Tocagen Expands Phase II/III Trial, Begins Enrolling in Canada

         Cachexia

        Two Phase III Anamorelin Trials Show Improved Lean Body Mass

         NCI CTEP-Approved Trials for the Month of March
        March 2016
        February 2016PDF

         

        Leukemia

        Phase III Blincyto Study Stopped Early After Meeting OS Primary Endpoint

        A phase III study of Blincyto met its primary endpoint of overall survival in patients with acute lymphoblastic leukemia following a prespecified interim analysis. The study was stopped early.

        The randomized, open-label TOWER study evaluated the efficacy of Blincyto (blinatumomab) versus the standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

        Patients were randomized in a 2:1 ratio to receive Blincyto or treatment with investigator choice of one of four protocol defined SOC chemotherapy regimens.

           

          Soft Tissue Sarcoma

          Halaven Study Improves Overall Survival In Liposarcomas and Leiomyosarcomas

          Full results from a phase III study showed improved median overall survival in unresectable locally advanced liposarcomas and leiomyosarcomas in patients receiving Halaven (eribulin), compared to dacarbazine.

          The clinical trial, study 309, included data from 452 adults, and was published in The Lancet, which also published an editorial discussing the study results.

          The study compared patients treated with eribulin mesilate (1.4 mg/msquared intravenously on days 1 and 8) and those treated with dacarbazine (850 mg/msquared, 1000 mg/msquared, or 1200 mg/msquared [dose dependent on center and clinician] intravenously on day 1). Additional endpoints included progression-free survival and quality of life.

             

            Breast Cancer

            OBI-822/821 Phase II/III Study Does Not Meet PFS Endpoint, But Shows Positive Results In Patients with Immune Response

            OBI Pharma Inc., announced topline results from a phase II/III study of OBI-822/821 (formerly OPT822/OPT821), which evaluated the clinical benefit and immunogenicity in patients with metastatic breast cancer. The study did not meet the primary efficacy endpoint of progression-free survival.

            However, patients who demonstrated an immune response showed highly significant improvement in progression-free survival and the secondary endpoint of overall survival is trending towards statistical significance. OBI-822/821 was generally well tolerated with no major safety concerns. Full results will be presented at an upcoming international scientific conference.

               

              Pancreatic Cancer

              Two Studies Evaluate 2nd Line Treatments Following Abraxane

               

              Non-Small Cell Lung Cancer

              Gilotrif Improves PFS Compared to Iressa in Phase IIb Trial

               

              Thyroid Cancer

              Study: Afirma Genomic Test Can Reduce Unnecessary Fine Needle Aspiration Biopsies

               

              NCI CTEP-Approved Trials for the Month of February

               

              Drugs and Targets

              • Gazyva Combination Approved In Follicular Lymphoma
              • FDA approves Afinitor for GI and lung NETs
              • Venetoclax receives third FDA Breakthrough Designation
              • FDA grants breakthrough designation to PKC412 (midostaurin)
              • FDA grants orphan drug designation to tazemetostat for malignant rhabdoid tumors
              • FDA grants orphan drug designation to CD101 IV for candidema
              February 2016
              January 2016PDF

               

              Melanoma

              Phase III Trial Binimetinib Increases PFS in NRAS-Mutant Melanoma vs. Dacarbazine

              Array BioPharma reported top-line results from the ongoing phase III clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, demonstrating that the study met its primary endpoint of improving progression-free survival when compared with dacarbazine treatment.

              The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm (HR=0.62, 95% CI 0.47-0.80, p < 0.001). Binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients. Binimetinib is a small molecule MEK inhibitor which targets key enzymes in the RAS/RAF/MEK/ERK pathway.

              Breast Cancer

              Survey of Breast Cancer Cell Function Identifies New Drug Uses, Combinations

              Researchers conducted a large analysis of breast cancer cell function, saying the results suggest dozens of new uses for existing drugs, new drug discovery targets, and new drug combinations.

              “This study represents the largest survey yet of how the genetic changes in breast cancer cells interfere with pathways critical to their growth and survival, pathways that might be targeted by combinations of new or existing drugs,” said lead study author Benjamin Neel, director of the Perlmutter Cancer Center at NYU Langone Medical Center.

              The study results were published in the journal Cell. The researchers combined genetic analyses of more breast cancer cell types than studied previously, new statistical methods, and comparisons with databases of molecular signatures and the effects of anti-cancer drugs.

              Ovarian Cancer

              Trial of 200,000 Women Shows Screening Can Reduce Mortality by 20 Percent

              One of the largest randomized trials ever has concluded that ovarian cancer screening may reduce ovarian cancer mortality by an estimated 20 percent after follow up of up to 14 years, but researchers say longer follow-up is needed to determine the ultimate mortality reduction and if screening the general population is cost effective.

              The United Kingdom Collaborative Trial of Ovarian Cancer Screening enrolled 202,638 women, aged 50-74 years, between 2001 and 2005 through 13 trial centers in England, Northern Ireland and Wales. The study results were published in The Lancet.

              The study tested the hypothesis that screening for ovarian cancer in the general population can reduce disease mortality without significant harm, in line with screening programs for other cancers.

              Colorectal Cancer

              Cervical Cancer

              Analysis Evaluates Moore Criteria for Bevacizumab Effectiveness

              NCI CTEP-Approved Trials for the Month of January
              Drugs and Targets

              • Opdivo-Yervoy combination granted accelerated approval in metastatic melanoma
              • Halaven approved for unresectable or metastatic liposarcoma
              • Zepatier approved for chronic hepatitis C
              • Health Canada grants conditional approval to Blincyto in Ph- acute lymphoblastic leukemia
              • FDA grants breakthrough designations to BI1482694 (HM61713) and venetoclax
              • Priority review granted to lenvatinib in renal cell carcinoma
              February 2016
              December 2015PDF

               

               Multiple Myeloma

              Head-to-Head Phase III Study Demonstrates Kyprolis Nearly Doubles PFS over Velcade

              Results from the phase III head-to-head ENDEAVOR study comparing Kyprolis to Velcade in patients with relapsed multiple myeloma showed that patients treated with Kyprolis achieved progression-free survival of 18.7 months compared to 9.4 months (HR=0.53; 95% CI: 0.44, 0.65; p<0.0001).

              The findings demonstrated that patients treated with Kyprolis (carfilzomib) plus dexamethasone lived twice as long without disease worsening as those treated with Velcade (bortezomib) plus dexamethasone.

              Also:

               Leukemia

              AML Patients Receiving PKC412 Midostaurin Show 23% OS Improvement in Phase III Trial

              Adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia who received the investigational compound PKC412 (midostaurin), plus standard induction and consolidation chemotherapy, experienced a 23 percent improvement in overall survival (HR=0.77, p=0.0074), compared to those treated with standard induction and consolidation chemotherapy alone.

              In the phase III RATIFY clinical trial, the median OS for patients in the PKC412 treatment group was 74.7 months (95% CI: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group.

              The trial evaluated the addition of either PKC412 or placebo to daunorubicin/cytarabine in the induction phase, followed by high-dose cytarabine in the consolidation phase; patients who achieved complete remission after consolidation chemotherapy continued treatment with PKC412 or placebo as a single agent for up to one year.

               Drugs and Targets

              FDA Approves Opdivo Injection for Renal Cell Carcinoma Patients

              FDA approved Opdivo (nivolumab) injection for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

              In the CheckMate-025 trial, patients treated with Opdivo achieved a median OS of 25 months (95% CI: 21.7-not estimable) versus 19.6 months (95% CI: 17.6-23.1) for everolimus, a current standard of care (HR: 0.73; [95% CI: 0.60-0.89; p=0.0018]), based on a prespecified interim analysis. In the study, the safety profile was consistent with prior Opdivo studies.

              Also:

              Pancreatic Cancer

               Liver Metastases

              Phase III Melphalan Trial Shows Improvement in Hepatic-PFS in Melanoma Patients

              December 2015

              NCI CTEP-Approved Studies for the Month of November

               

              The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.

               

              Phase I

              CITN-12: Phase I Study of MK-3475 (Pembrolizumab) in Patients with Human Immunodeficiency Virus (HIV) and Relapsed/Refractory or Disseminated Malignant Neoplasm. Cancer Immunotherapy Trials Network; Uldrick, Thomas S. (301) 402-6296

               

              PBTC-047: Phase I Trial of Panobinostat in Children with Diffuse Intrinsic Pontine Glioma. Pediatric Brain Tumor Consortium; Monje, Michelle. (650) 736-0885

               

              Phase II

              ADVL1522: A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; IND#: 126953, NSC#: 783609) in Children with Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma. Children’s Oncology Group; Geller, James Ian. (513) 636-6312 X 6312

               

              AOST1321: Phase 2 Study of Denosumab (IND# 127430, NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma. Children’s Oncology Group; Janeway, Katherine Anne. (617) 632-4994

               

              AOST1421: A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# 764038, IND# 4308) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma. Children’s Oncology Group; Hingorani, Pooja. (602) 546-0920

               

              Other Phases

              AALL14B7-Q: Screening Low-Hypodiploid B-ALL for Pro-B Phenotypes. Children’s Oncology Group; Carlson, Christopher. (206) 667-7034

               

              AAML15B5-Q: The Role of Id1 in Leukemogenesis. Children’s Oncology Group; Wang, Lan. (305) 243-8920

               

              AEWS15B1-Q: Development of Specific and Reversible LSD1 Inhibitors for Ewing’s Sarcoma. Children’s Oncology Group; Lessnick, Stephen L. (415) 476-3831

               

              AEWS15B1-Q: Development of Specific and Reversible LSD1 Inhibitors for Ewing’s Sarcoma. Children’s Oncology Group; Lessnick, Stephen L. (415) 476-3831

               

              ANHL14B1-Q: Genomic Analysis of Pediatric Anaplastic Large Cell Lymphoma ALCL. Children’s Oncology Group; Leventaki, Vasiliki. (901) 595 7531

               

              APEC14B1: The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study. Children’s Oncology Group; Adamson, Peter C. (215) 590-6359

               

              E1608T2: Inherited Markers as Predictors of Adverse Events and Survival Among Melanoma Patients Treated with Ipilimumab. ECOG-ACRIN Cancer Research Group; Nathanson, Katherine Leah. (215) 573-9840

               

              S1417CD: Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer. SWOG; Shankaran, Veena (206) 288-7456

              December 2015
              November 2015PDF

               

               Melanoma

              Keytruda Shows Anti-Tumor Activity in Three Combinations and Phase III Trial

              Merck presented three studies investigating the use of Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with three other immunotherapies—epacadostat, Imlygic (talimogene laherparepvec), and ipilimumab—in patients with advanced melanoma.

              Keytruda showed anti-tumor activity in all three combinations studied. The findings were featured in separate oral presentations at the International Congress of the Society for Melanoma Research, in San Francisco.

              Additionally, updated data presented from a phase III study of Keytruda as a single agent showed superior overall response rates and progression free survival compared to ipilimumab in ipilimumab-naïve patients, with twice as many patients achieving PFS on Keytruda compared to ipilimumab.

               Drugs and Targets

              FDA Approves Ninlaro and Darzalex For the Treatment of Multiple Myeloma

              FDA approved Ninlaro (ixazomib), developed by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor.

              The approval was based on an improvement in progression- free survival in a multicenter, randomized, double-blind, placebo-controlled trial enrolling 722 patients with multiple myeloma who had received one to three prior lines of therapy. Patients were randomized in a 1:1 ratio to either the combination of ixazomib, lenalidomide and dexamethasone (n=360) or the combination of placebo, lenalidomide and dexamethasone (n=362). Patients continued treatment until disease progression or unacceptable toxicity.

               Lymphoma

              Lenalidomide-Rituximab Combination Shows Benefits in Mantle Cell Lymphoma

              A combination therapy lacking many of the debilitating effects of traditional cancer treatment effectively manages mantle cell lymphoma, shrinking the malignancy and inducing remissions in the majority of patients, according to new research from Weill Cornell Medicine.

              The phase II study demonstrated that lenalidomide, in combination with rituximab, provides an effective alternative to chemotherapy. More than 90 percent of patients in the small efficacy trial responded to the therapy, with their cancer shrinking by more than half, and two-thirds of that group had no evidence of detectable tumor growth after treatment.

              Glioblastoma

              ICT-107 Boosts Overall Survival by 10 Percent In Phase II Trial

               Childhood Cancer

              Researchers: All Pediatric Patients, Regardless of Family History, Could Benefit from Genomic Screening

               Cancer Genomics

              TCGA Researchers Identify 7 Subtypes of Prostate Cancer And 2 Drivers of Papillary RCC

               Lung Cancer

              FDA Requests Data from Clovis For Rociletinib NDA in NSCLC

               NCI CTEP-Approved Studies for the Month of November
              November 2015
              October 2015PDF

               

               Drugs and Targets

              FDA Approves Imlygic as First Oncolytic Viral Therapy in the U.S., for Melanoma

              FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.

              Imlygic, developed by Amgen, is indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic has not been shown to improve overall survival or have an effect on visceral metastases.

              Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce granulocyte-macrophage colony-stimulating factor, an immunostimulatory protein. Imlygic causes cell lysis rupturing tumors and releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response. However, the exact mechanism of action is unknown, according to Amgen.

              Also:

               Breast Cancer

              Phase III Trial Finds Equivalent OS Rates Between APBI Brachytherapy and Whole Breast Irradiation Therapy

              A prospective, randomized, multicenter phase III study comparing accelerated partial breast irradiation with interstitial multicatheter brachytherapy to whole breast irradiation showed that APBI brachytherapy lead to equivalent overall survival and local and regional cancer control rates, as compared to WBI after breast conserving surgery for selected patients with early stage breast cancers.

              The primary objective of the trial was to assess the role of APBI brachytherapy alone compared to whole breast irradiation with boost in a defined group of patients with invasive (stage I-IIA) breast cancer or ductal carcinoma in situ (stage 0) who underwent breast-conserving surgery.

               Non-Small Cell Lung Cancer

              Patients Receiving IMRT Had Less Toxicity Compared to 3D CRT, Study Finds

              Patients with locally advanced non-small cell lung cancer that received intensity modulated radiation therapy had less severe lung toxicity and were able to better tolerate their chemotherapy compared to patients who received 3D conformal radiation therapy, according to a secondary analysis of a large phase III trial.

              The study, NRG/RTOG 0617, originally enrolled patients from 2007 to 2011, and compared a high dose of 74 Gy to the standard dose of 60 Gy. All underwent concurrent chemotherapy (carboplatin/paclitaxel, with or without cetuximab) and either 3D CRT or IMRT. In the study, 482 patients were treated with radiation—53 percent with IMRT and 47 percent with 3-D CRT.

              Prostate Cancer

              Phase III Trial Demonstrates Shorter, Hypofractionated RT Can Deliver Similar Results Compared to Conventional RT

               Mesothelioma

              WT1 Vaccine Doubles PFS In MPM Patients in Phase II Trial

               Renal Cell Carcinoma

              Study: Lenvatinib-Everolimus Combination Can Improve PFS

               Carcinoid Syndrome

              Telotristat Etiprate Demonstrates Clinical Benefit in Phase III Study

               Cervical Cancer

              Outreach Program Boosts HPV Vaccine Three-Dose Series Completion

               NCI CTEP-Approved Trials For the Month of October
              November 2015
              September 2015PDF

               

               Lung Cancer

              Avastin Biosimilar Meets Phase III Endpoints, Demonstrating Clinical Equivalence

              Amgen and Allergan plc. announced positive top-line results from Avastin biosimilar candidate ABP 215, which met its primary and secondary endpoints in a phase III trial in advanced non-squamous non-small cell lung cancer.

              ABP 215 is being developed as a biosimilar to Avastin, a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2.

              The primary endpoint, objective response rate, was within the prespecified margin for ABP 215 compared to Avastin (bevacizumab), showing clinical equivalence.

               Neuroendocrine Tumors

              Afinitor Extends PFS by 7.1 Months in Gastrointestinal and Lung NETs

              Novartis announced results of a phase III study showing Afinitor (everolimus) tablets reduced the risk of progression by 52 percent (HR=0.48; 95% CI, 0.35-0.67; p<0.00001) compared to placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin.

              The study, RADIANT-4, was presented at the European Cancer Congress in Vienna, Austria.

              Additionally, the data show Afinitor, a mammalian target of rapamycin (mTOR) inhibitor, extended median progression free survival by 7.1 months: median PFS by central review was 11.0 months (95% CI, 9.23-13.3) in the Afinitor arm and 3.9 months (95% CI, 3.58-7.43) in the placebo arm.

              Also:

               Prostate Cancer

              Additional Analyses Show Custirsen Lowered Serum Clusterin Levels in CRPC Patients

              OncoGenex Pharmaceuticals Inc. presented results from additional exploratory analyses of the phase III SYNERGY trial, demonstrating that custirsen treatment significantly lowered serum clusterin levels from baseline in men with metastatic castrate-resistant prostate cancer.

              The data, presented at the 2015 European Cancer Congress in Vienna, Austria, showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes.

              Myeloid Malignancies

              Two NEJM Papers Evaluate Imetelstat in Myelofibrosis and Essential Thrombocythemia

               Bladder Cancer

              Cyramza Increases PFS In Phase II Study of Patients Who Failed Platinum Therapy

               NCI CTEP-Approved Trials For the Month of September
               Drugs and Targets

              • FDA Approves Varubi for CINV
              • FDA Grants Priority Review for MCNA in invasive bladder cancer
              • FDA Grants Priority Review to Kyprolis in relapsed multiple myeloma
              October 2015
              August 2015PDF

               

              Leukemia

              High-Risk Subset of CLL Patients Shows Benefit in Phase II Trial

              A statistically significant percentage of chronic lymphocytic leukemia patients in a phase II clinical trial responded to venetoclax therapy.

              The open-label study, sponsored by AbbVie, met its primary endpoint, achieving overall response rates in patients with relapsed/refractory or previously untreated CLL with 17p deletion, according to an independent review analysis.

              The study enrolled 157 patients, 107 in the main study cohort evaluating efficacy, and 50 patients in the safety expansion cohort.

              The primary efficacy endpoint is overall response rate, and the primary safety endpoints are the number and percentage of patients who experienced treatment-related adverse events, changes in physical exam findings, including vital signs, changes in clinical laboratory test results and changes in cardiac assessment findings.

               

              Lung Cancer

              Atezolizumab Immunotherapy Meets Response Endpoint in Phase II NSCLC Study

              A phase II study of atezolizumab immunotherapy met its primary endpoint, shrinking tumors in patients with locally advanced or metastatic non-small cell lung cancer whose disease expressed PD-L1.

              The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the medicine.

              The study, BIRCH, is an open-label, multicenter, single-arm study that evaluated the safety and efficacy of atezolizumab in 667 people. Results from the study will be presented at an upcoming medical meeting, according to the drug’s sponsor, Genentech, a member of the Roche Group.

              Also:

               

              Drugs and Targets

              European Commission Approves Unituxin in Pediatric High-Risk Neuroblastoma

              The European Commission granted a marketing authorization for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation.

              Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and isotretinoin.

              The European approval was based on demonstration of improved event-free survival and overall survival in a multicenter, open-label, randomized trial (ANBL0032) sponsored by NCI under a Cooperative Research and Development Agreement with the drug’s sponsor, United Therapeutics Corp., and conducted by the Children’s Oncology Group.

               

              Liver Cancer

              ThermoDox plus RFA Increase OS By 58 Percent in HEAT Study

               

              Carcinoid Syndrome

              Oral Telotristat Etiprate Trial Meets Phase III Primary Endpoint

               

              NCI CTEP-Approved Trials for the Month of August

              August 2015
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