Top News from 59th ASH Annual Meeting 2017

Sustained Benefit in Patients with Relapsed/Refractory Mantle Cell Lymphoma Demonstrated by 3.5-Year Follow-Up Data of IMBRUVICA® (ibrutinib)

December 9, 2017

Janssen Research & Development, LLC (Janssen) has announced results of a pooled analysis of relapsed/refractory (r/r) mantle cell lymphoma (MCL) patients treated with IMBRUVICA® (ibrutinib). The extended follow-up data demonstrated that patients treated with IMBRUVICA earlier (after first relapse) experienced the best clinical outcomes, in terms of both efficacy and tolerability. IMBRUVICA, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.

Sprycel (dasatinib) Added to Standard Chemotherapy Demonstrates Three-Year Survival Benefit in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

December 9, 2017

Bristol-Myers Squibb Company has announced data from the phase 2 CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) treated with Sprycel (dasatinib) added to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone. The combination demonstrated an event-free survival (EFS) rate, the study’s primary endpoint, of 65.5% (95% CI: 57.7 to 73.7), and an overall survival (OS) rate of 91.5% (95% CI: 84.2 to 95.5) at three years. Sprycel and chemotherapy were generally well-tolerated in pediatric Ph+ ALL patients.

Celgene Corporation and bluebird bio Announce Updated Results from Ongoing Multicenter Phase 1 Study of bb2121 Anti-BCMA CAR T Cell Therapy in Patients with Late Stage Relapsed/Refractory Multiple Myeloma at ASH Annual Meeting

December 10, 2017

Celgene Corporation and bluebird bio, Inc. have announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR T cell therapy, in 21 patients with late-stage relapsed/refractory multiple myeloma were presented in an oral presentation at the ASH Annual Meeting. The objective of this Phase 1 dose-escalation study is to evaluate safety and efficacy of bb2121 and determine a recommended Phase 2 dose.

Primary analysis results from Novartis pivotal JULIET trial show Kymriah(TM) (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL

December 10, 2017

Novartis has announced updated results from the JULIET clinical trial demonstrating sustained responses with Kymriah TM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The data from this pivotal trial, led by researchers from the University of Pennsylvania (Penn), show an overall response rate (ORR) of 53% (95% confidence interval [CI], 42% – 64%; p<0.0001), with 40% achieving a complete response (CR) and 14% achieving a partial response (PR) among 81 infused patients with three or more months of follow-up or earlier discontinuation. At six months from infusion, the ORR was 37% with a CR rate of 30%. The median duration of response was not reached.

Four-Year Phase 3 Data Analysis Shows Durability of Response of Jakafi® (ruxolitinib) in Patients with Polycythemia Vera

December 10, 2017

Incyte Corporation has announced new 208-week (4-year) follow-up data from the ongoing, global, multi-center, open-label Phase 3 RESPONSE study of Jakafi® (ruxolitinib) comparing the efficacy and safety of Jakafi with best available therapy (BAT) in patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU). The pre-planned data analysis showed a durable primary response to Jakafi in patients with PV who are resistant to or intolerant of HU and the overall safety profile for Jakafi remained consistent with previously reported 80-week RESPONSE data. The results were shared in an oral presentation at the ASH Annual Meeting.

KYPROLIS® (carfilzomib) Extended Overall Survival In Patients With Relapsed Or Refractory Multiple Myeloma In Phase 3 ASPIRE Trial

Dec. 11, 2017

Amgen has announced new results showing the positive overall survival (OS) findings from the final analysis of the Phase 3 ASPIRE trial. The study met the key secondary endpoint of OS, demonstrating that the addition of KYPROLIS® (carfilzomib) to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent versus lenalidomide and dexamethasone alone (Rd) and extended survival by 7.9 months in patients with relapsed or refractory multiple myeloma (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 – 0.95; p = 0.0045).

Phase II data showed Roche’s investigational polatuzumab vedotin plus bendamustine and MabThera/Rituxan (BR) increased complete response rates compared to BR alone in previously treated aggressive lymphoma

December 11, 2017

Roche has announced positive results from the randomised phase II GO29365 study that compared polatuzumab vedotin in combination with bendamustine plus MabThera® / Rituxan® (rituximab) (BR) against BR alone in people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant. The study met its primary endpoint, demonstrating that the addition of polatuzumab vedotin to BR increased complete response (CR) rates from 15% to 40% (p=0.012) at the end of treatment, as measured by positron emission tomography (PET) and assessed by an independent review committee (IRC). No unexpected safety signals were observed with the addition of polatuzumab vedotin to BR.

FDA Accepts Supplemental Biologics License Application (sBLA), Assigns Priority Review to Merck’s KEYTRUDA® (pembrolizumab) for Treatment of Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

December 11, 2017

Merck, known as MSD outside the United States and Canada, has announced findings from the phase 2 KEYNOTE-170 trial investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in the cohort of patients with relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma. In the PMBCL cohort of KEYNOTE-170, KEYTRUDA demonstrated an overall response rate (ORR) of 41 percent (n=12/29), including a 24 percent (n=7/29) complete response rate and a 17 percent (n=5/29) partial response rate, in patients who relapsed after or were refractory to autologous stem cell transplant (ASCT), or were ineligible for ASCT and failed two or more prior lines of therapy.

Seattle Genetics and Bristol-Myers Squibb Highlight Interim Results from Phase 1/2 Study Evaluating the Combination of ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab) in Relapsed or Refractory Hodgkin Lymphoma

December 11, 2017

Seattle Genetics, Inc. and Bristol-Myers Squibb Company have highlighted updated interim results from an ongoing phase 1/2 clinical trial evaluating the combination of ADCETRIS (brentuximab vedotin) and Opdivo (nivolumab) in relapsed or refractory classical Hodgkin lymphoma (HL). The data reported from 62 patients, including 60 evaluable for response, were featured in an oral presentation and selected to be included in the 2018 Highlights of ASH post-meeting program. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival. ADCETRIS and Opdivo are not approved in combination for the treatment of relapsed or refractory HL or for other indications.

DARZALEX® (daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible

December 12, 2017

Janssen Research & Development, LLC has announced data from the Phase 3 ALCYONE study, showing that DARZALEX® (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) significantly improved clinical outcomes, including reducing the risk of disease progression or death by 50 percent, in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).

AbbVie Announces Phase 3 Study of VENCLEXTA™/ VENCLYXTO™ (venetoclax) in Combination with Rituxan® (rituximab) Meets its Primary Endpoint

December 12, 2017

AbbVie has announced the first presentation of efficacy and safety results from MURANO, an international, multicenter, open-label, randomized Phase 3 study of VENCLEXTA™/VENCLYXTO™ (venetoclax) in combination with Rituxan® (rituximab) compared with bendamustine in combination with Rituxan in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). Investigator-assessed results showed that patients with R/R CLL achieved significantly prolonged median progression-free survival (PFS) with VENCLEXTA/VENCLYXTO in combination with Rituxan [median PFS, not reached], compared with bendamustine in combination with Rituxan [median PFS, 17.0 months; hazard ratio, 0.17; 95% CI, 0.11–0.25; P<0.0001].

Top News from 59th ASH Annual Meeting 2017 last edit: 2017-12-15T17:05:56+00:00 da Luca

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