Top News from ASCO 2018

All The Most Important News and Updates form ASCO 2018

Preliminary Data for NKTR-214 in Combination with Opdivo (nivolumab) for Patients with Stage IV Metastatic Melanoma, Renal Cell Carcinoma, and Urothelial Cancers Presented at ASCO 2018

June 2, 2018

Nektar Therapeutics and Bristol-Myers Squibb have announced presentation of preliminary data from the ongoing PIVOT Phase 1/2 Study, which is evaluating the combination of Bristol-Myers Squibb’s Opdivo (nivolumab) with Nektar’s investigational medicine, NKTR-214. The preliminary results presented at the 2018 American Society of Clinical Oncology (ASCO) reported safety, efficacy and biomarker data for patients enrolled in the Phase 1 dose-escalation stage of the study and for the first patients consecutively enrolled in select dose expansion cohorts in Phase 2.

Loxo Oncology Announces Positive Interim Clinical Data from LOXO-292 Dose Escalation Trial in RET-Altered Cancers 

June 2, 2018

Loxo Oncology, Inc., a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, has announced interim clinical data from the Loxo Oncology global Phase 1 LIBRETTO-001 (LOXO-292 Investigated to Block RET-altered Tumors) dose escalation trial. LOXO-292 is an investigational, highly potent and selective RET inhibitor.

Phase III IMpower131 study showed Tecentriq (atezolizumab) plus chemotherapy (carboplatin and Abraxane) reduced the risk of disease worsening or death for people with advanced squamous non-small cell lung cancer

June 2, 2018

Roche has announced that results from the Phase III IMpower131 study showed Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) by 29 percent compared with chemotherapy (carboplatin and nab-paclitaxel) alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC) (median PFS=6.3 vs. 5.6 months; hazard ratio [HR]=0.71, 95% CI: 0.60, 0.85, p=0.0001). The 12-month PFS rate was doubled for people who received the Tecentriq combination (24.7 percent) compared to those who received chemotherapy alone (12.0 percent). A statistically significant overall survival (OS) benefit was not observed at the interim analysis, and the study will continue as planned. The safety profile of the Tecentriq plus chemotherapy combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.

Phase 3 A.R.R.O.W. Interim Analysis Shows Once-Weekly 70 mg/m2 KYPROLIS® (carfilzomib) Regimen Significantly Extended Progression-Free Survival Versus A Twice-Weekly 27 mg/m2 Regimen In Patients With Relapsed And Refractory Multiple Myeloma

June 2, 2018

Amgen has announced results from the Phase 3 A.R.R.O.W. trial of a once-weekly KYPROLIS® (carfilzomib) dosing regimen in patients with relapsed and refractory multiple myeloma. In the trial, KYPROLIS administered once-weekly at 70 mg/m2 with dexamethasone (once-weekly Kd) achieved superior progression-free survival (PFS) and overall response rates (ORR), with a comparable safety profile, versus twice-weekly KYPROLIS at 27 mg/m2 and dexamethasone (twice-weekly Kd). These data were presented during an oral session at the 54th ASCO Meeting and simultaneously published in The Lancet Oncology.

New Novartis data presented at ASCO find nearly half of CML patients treated with Tasigna® remain in remission almost three years after stopping therapy

June 2, 2018

New Novartis data from two long-term Treatment-free Remission (TFR) studies in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP) were presented during the 54th ASCO Meeting in Chicago. Results from the open-label Phase II trials, ENESTop and ENESTfreedom, show sustained TFR in patients treated with both front-line and second-line Tasigna® (nilotinib) therapy. The 144-week trials evaluate the potential to maintain molecular response (MR) after stopping therapy in eligible adult patients with Ph+ CML-CP.

Third Novartis Phase III trial shows Kisqali® combination therapy significantly improves PFS in HR+/HER2- advanced breast cancer

June 3, 2018

Novartis has announced positive results from the third Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. MONALEESA-3 showed Kisqali plus fulvestrant significantly prolonged progression-free survival (PFS) compared to fulvestrant alone in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer. MONALEESA-3 is the largest phase III trial to evaluate efficacy and safety of a CDK4/6 inhibitor plus fulvestrant in multiple advanced breast cancer patient populations – first-line and second-line settings. These data were presented as an oral presentation at ASCO in Chicago and published simultaneously in the Journal of Clinical Oncology.

Results of Phase III RELEVANCE Study Comparing REVLIMID plus Rituximab (R²) Versus Rituximab Plus Chemotherapy in Patients with Previously Untreated Follicular Lymphoma Presented at ASCO 2018

June 3, 2018

Celgene Corporation has announced additional results from RELEVANCE, a phase III, randomized, open-label, international clinical study conducted in partnership with the Lymphoma Academic Research Organisation (LYSARC), were presented at ASCO in Chicago. This investigational study evaluated REVLIMID® (lenalidomide) plus rituximab (R2), followed by R2 maintenance, an investigational regimen, compared to the standard of care treatment of rituximab plus chemotherapy (R-chemo: R-CHOP, R-bendamustine or R-CVP) followed by rituximab maintenance in patients with previously untreated follicular lymphoma. Investigators found that treatment with a chemotherapy-free R2 regimen offered numerically similar efficacy results for the primary endpoints of progression free survival (PFS) and complete response or unconfirmed complete response (CR/CRu) at 120 weeks with a different safety profile than treatment with the conventional R-chemo standard. As previously disclosed, the study did not achieve the primary endpoints of superior PFS and CR/CRu.

Merck Presents Update on Tepotinib in Advanced Lung Cancer

June 3, 2018

Merck KGaA, a leading science and technology company, announced that the investigational, targeted therapy tepotinib has shown clinical activity in an ongoing Phase II study of patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations.

Celgene Announces Updated Safety and Efficacy Data from the TRANSCEND Trial of liso-cel (JCAR017) in Patients with Relapsed or Refractory B-cell non-Hodgkin Lymphoma

June 3, 2018

Celgene Corporation has announced updated six-month safety and efficacy data from the TRANSCEND (NHL-001) study of lisocabtagene maraleucel (liso-cel; JCAR017), an investigational CD19-directed CAR T cell therapy, in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL) in a presentation at the ASCO

Eisai and Merck Announce Data from Investigational Studies of LENVIMA® (lenvatinib) and KEYTRUDA® (pembrolizumab) Combination Therapy in Four Different Tumor Types

June 4, 2018

Eisai Co., Ltd. and Merck & Co., Inc. have announced that results from presentations of new data and analyses of LENVIMA® (lenvatinib), an orally available kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in four different tumor types: unresectable hepatocellular carcinoma (HCC), squamous cell carcinoma of the head and neck (SCCHN), advanced renal cell carcinoma (RCC), and advanced endometrial carcinoma (EC).

LYNPARZA® (olaparib) in Combination with Abiraterone Delayed Disease Progression in Metastatic Castration-Resistant Prostate Cancer

June 4, 2018

AstraZeneca and Merck & Co. presented data at ASCO 2018, which showed clinical improvement in median radiologic progression-free survival (rPFS) with Lynparza (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a standard of care, in metastatic castration-resistant prostate cancer (mCRPC). Lynparza is being jointly developed and commercialised by AstraZeneca and MSD.

Opdivo (nivolumab) 3 mg/kg Demonstrates Sustained, Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) 10 mg/kg for Broad Range of Patients with Resected Stage III or IV Melanoma

June 4, 2018

Bristol-Myers Squibb Company has announced updated results from the Phase 3 CheckMate -238 trial evaluating Opdivo (nivolumab) versus Yervoy (ipilimumab) in patients with stage IIIB/C or stage IV melanoma who are at high risk of recurrence following complete surgical resection. In updated results from the study, Opdivo continued to demonstrate statistically longer recurrence-free survival (RFS) of 62.6%, the primary endpoint of the study, versus 50.2% for Yervoy (HR: 0.66, P<0.0001) at a minimum follow-up of 24 months across key subgroups, including disease stages and BRAF mutation status.

Moxetumomab pasudotox pivotal data in patients with previously-treated hairy cell leukaemia presented at the 2018 ASCO 

June 4, 2018

AstraZeneca and MedImmune, its global biologics research and development arm, have presented results from the Phase III (‘1053’) clinical trial that evaluated moxetumomab pasudotox in 80 patients with relapsed or refractory hairy cell leukaemia (HCL) who had received at least two prior lines of therapy. Moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin, showed a 75% objective response (OR) rate, a 41% complete response (CR) rate, and a 30% durable CR rate (primary endpoint). The majority of patients with a complete response had a durable response (73%; 24/33) and achieved a negative minimal residual disease (MRD) status (82%; 27/33). .

Two Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses with BAVENCIO® (avelumab)

June 4, 2018

Merck KGaA and Pfizer have announced that updated efficacy and safety data from the pivotal JAVELIN Merkel 200 trial of BAVENCIO® (avelumab) in patients with metastatic Merkel cell carcinoma (mMCC) were presented as an oral abstract session at ASCO. At this two-year follow-up update of the pivotal study, BAVENCIO continues to demonstrate clinically meaningful durable responses and stable rates of progression-free survival (PFS) and overall survival (OS) from previous analyses in patients who responded to this treatment. Clinical activity was observed across all patient subgroups, irrespective of PD-L1 expression in tumor tissue or Merkel cell polyomavirus status. The safety profile for BAVENCIO in this trial has not changed with longer follow-up and remains consistent with that observed in the overall JAVELIN clinical development program.

Merck’s KEYTRUDA® (pembrolizumab) Showed Promising Anti-Tumor Activity in Patients with Advanced Small Cell Lung Cancer (SCLC) in Phase 2 KEYNOTE-158 Study

June 4, 2018

Merck, known as MSD outside the United States and Canada, has announced interim data from a cohort of the Phase 2 KEYNOTE-158 study evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients with previously treated advanced small cell lung cancer (SCLC). Findings showed an overall response rate (ORR) of 18.7 percent in patients in the SCLC cohort (95% CI, 11.8–27.4), the primary endpoint of the study. Additionally, in a pre-specified exploratory analysis, ORR was 35.7 percent in patients whose tumors expressed PD-L1 with a combined positive score (CPS) of ?1 (95% CI, 21.6–52.0).

Dacomitinib Shows More Than Seven-Month Improvement in Overall Survival Compared to An Established Therapy in Advanced NSCLC with EGFR-Activating Mutations

June 4, 2018

Pfizer Inc. has announced overall survival (OS) data from the ARCHER 1050 trial evaluating dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations compared to gefitinib. The trial showed a median OS of 34.1 months for patients receiving dacomitinib (95% CI: 29.5, 37.7), representing a more than seven-month improvement compared to 26.8 months with gefitinib (95% CI: 23.7, 32.1). The OS data from ARCHER 1050 were presented as an oral presentation at ASCO and have been published simultaneously in the Journal of Clinical Oncology.

Kite Announces New Data Analyses for CAR T Therapy in Patients with Blood Cancers

June 4, 2018

Kite, a Gilead Company, has announced new analyses from the ZUMA chimeric antigen receptor T (CAR T) cell therapy development program. The results include analyses of the ZUMA-1 study of Yescarta® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma showing that response status may predict rates of progression-free survival (PFS) and that treatment responses were consistent across prior lines of therapy. Additionally, an analysis of the ZUMA-3 study evaluating investigational KTE-C19 for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) showed that patients experienced manageable safety and encouraging efficacy irrespective of prior blinatumomab use.

Opdivo Plus Chemotherapy Showed Improved Progression-Free Survival Versus Chemotherapy in First-Line Lung Cancer Patients with PD-L1 <1%, in CheckMate -227 Study 

June 4, 2018

Bristol-Myers Squibb Company has announced results from a part of the Phase 3 CheckMate -227 trial that evaluated Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) and Opdivo plus chemotherapy versus chemotherapy in patients with first-line advanced non-small cell lung cancer (NSCLC) with PD-L1 expression <1%, across squamous and non-squamous tumor histologies (Part 1b).

Top News from ASCO 2018 last edit: 2018-06-24T18:14:56+00:00 da Luca

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