Clovis Oncology Presents Comprehensive Dataset from Successful Phase 3 Ariel3 Maintenance Treatment Trial of Rucaparib In Advanced Ovarian Cancer

clovis-oncologySep. 7, 2017

Clovis Oncology has announced the first presentation of a comprehensive dataset from its Phase 3 ARIEL3 study of rucaparib at the 2017 European Society for Medical Oncology (ESMO) Congress. The ARIEL3 study successfully achieved its primary endpoint and key secondary endpoint, demonstrating improved progression-free survival (PFS) by both investigator review and blinded independent central review (BICR) in each of the three populations studied.

Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Carboplatin (pem/carbo) Demonstrated Continued Benefit in Overall Response Rates and Progression-Free Survival Compared to Pem/Carbo Alone in Patients with First-Line Nonsquamous NSCLC

merck_logo_biotechjobs-300x87September 8, 2017

Merck has announced updated results from Cohort G of the phase 2 KEYNOTE-021 trial investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed and carboplatin (pem/carbo) in patients with previously untreated advanced nonsquamous non-small cell lung cancer (NSCLC), with or without PD-L1 expression. With an additional five months of follow-up, significant improvements observed in prior analyses were maintained, including improvements in overall response rate (ORR) and progression-free survival (PFS) for KEYTRUDA + pem/carbo compared to pem/carbo alone. With a median of 18.7 months of follow-up, more than half of patients in the KEYTRUDA combination arm responded to treatment compared to approximately one-third in the pem/carbo arm (ORR of 56.7% vs. 31.7% [95% CI, 7.2-40.9], p=0.0029). The risk of progression or death continued to be reduced by nearly half with KEYTRUDA + pem/carbo compared to pem/carbo alone (HR 0.54 [95% CI, 0.33-0.88, p=0.0067]). In addition, despite the crossover design, a trend in improvement in overall survival continues to be seen for KEYTRUDA + pem/carbo compared to pem/carbo alone (HR, 0.59 [95% CI, 0.34-1.05, p=0.03]).

AstraZeneca presented superior progression-free survival for Imfinzi in the PACIFIC trial of patients with locally-advanced unresectable lung cancer 

astrazeneca8 September 2017

AstraZeneca and MedImmune, its global biologics research and development arm, have presented the full PFS data from a planned interim analysis of the Phase III PACIFIC trial. Results show that Imfinzi (durvalumab) demonstrated a statistically-significant and clinically-meaningful improvement in PFS compared to current standard of care with active surveillance in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT).

Two Pivotal Opdivo (nivolumab) Trials Show Three-Year Survival Benefit in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer

BMS logoSeptember 8, 2017

Bristol-Myers Squibb Company has announced three-year overall survival (OS) data from CheckMate -017 and CheckMate -057, two pivotal Phase 3 randomized studies evaluating Opdivo versus docetaxel in patients with previously treated metastatic non-small cell lung cancer (NSCLC). In CheckMate -017, a trial in previously treated squamous NSCLC, 16% of patients treated with Opdivo were alive at three years (21/135) versus 6% of those treated with docetaxel (8/137) (HR 0.62; 95% CI: 0.48 to 0.80). In CheckMate -057, a trial in previously treated non-squamous NSCLC, 18% of patients treated with Opdivo were alive at three years (49/292) versus 9% of those treated with docetaxel (26/290) (HR 0.73; 95% CI: 0.62 to 0.88). Similar to prior reports, an OS benefit was observed across histologies, and three-year survivors included patients whose tumors expressed PD-L1 and those that did not. With three years’ minimum follow-up, no new safety signals were identified for Opdivo, and the safety profile across both trials was consistent with prior reports.

AstraZeneca’s Tagrisso shows benefits over standard of care in 1st-line EGFR-mutated lung cancer

astrazenecaSeptember 8, 2017

AstraZeneca has presented the full results of the Phase III FLAURA trial, which support Tagrisso’s (osimertinib) clear potential as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Results of the Phase III FLAURA trial were included at the Presidential Symposium of the ESMO 2017 Congress in Madrid, and demonstrate a superior, clinically-meaningful PFS advantage with Tagrisso compared with current SoC EGFR-TKIs (erlotinib or gefitinib).

Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma

merck_logo_biotechjobs-300x87September 9, 2017

Merck and Incyte Corporation have announced updated data from the ongoing Phase 1/2 ECHO-202 trial (KEYNOTE-037) evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma. Among all patients with advanced melanoma, including treatment-naïve and treatment-experienced, data showed an overall response rate (ORR) of 56 percent (n=35/63) in patients treated with the combination of epacadostat and KEYTRUDA; median progression-free survival (PFS) was 12.4 months, with PFS rates of 65 percent at six months, 52 percent at 12 months, and 49 percent at 18 months. Results were generally consistent across dosing schedules of epacadostat combined with KEYTRUDA, including epacadostat 100 mg BID, the epacadostat dose being studied in the Phase 3 ECHO-301 trial.

Lilly Builds Upon Body of Clinical Evidence for CYRAMZA® (ramucirumab) with Phase 3 RANGE Data Demonstrating Superior Progression-Free Survival in Advanced or Metastatic Urothelial Cancer

Eli Lilly LogoSeptember 10, 2017

At the ESMO 2017 Congress, Phase 3 RANGE data from Eli Lilly and Company were presented in the Presidential Symposium. These are the first detailed results from the global, randomized, double-blinded, placebo-controlled RANGE study of CYRAMZA® (ramucirumab), in combination with docetaxel, in patients with advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. The data showed a statistically significant improvement in progression-free survival (PFS) in patients treated with ramucirumab plus docetaxel when compared to those who received placebo plus docetaxel, with a 46 percent prolongation in median PFS.

Opdivo (nivolumab) Demonstrates Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) for Patients with Resected High-Risk Melanoma in Phase 3 CheckMate -238 Study

BMS logoSeptember 10, 2017

Bristol-Myers Squibb Company has announced today treatment with Opdivo (nivolumab) 3 mg/kg resulted in a significant improvement in recurrence-free survival (RFS) compared to Yervoy (ipilimumab) 10 mg/kg in patients with stage IIIb/c or stage IV melanoma following complete surgical resection. Following the July 5 announcement of topline results, detailed findings from the phase 3 CheckMate -238 study were highlighted during the ESMO 2017 Congress.

Merck’s KEYTRUDA® (pembrolizumab) Continues to Show Overall Survival Benefit Over Chemotherapy with Nearly Two Years Follow-Up in Previously Treated Patients with Advanced Urothelial Carcinoma, Post-Platinum Failure

merck_logo_biotechjobs-300x87September 10, 2017

Merck has announced updated results from the phase 3 KEYNOTE-045 trial evaluating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial carcinoma (a type of bladder cancer) with disease progression on or after platinum-containing chemotherapy (post-platinum failure). Updated data show that with median follow-up of 22.5 months, KEYTRUDA continues to demonstrate an overall survival (OS) benefit over investigator’s choice of paclitaxel, docetaxel or vinflunine as a second-line therapy, post-platinum failure, regardless of PD-L1 expression (HR, 0.70 [95% CI, 0.57-0.86], p=0.0003).

Opdivo Plus Yervoy Combination Demonstrated Superior Overall Survival and Showed Durable Responses in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma in Phase 3 CheckMate -214 Trial

BMS logoSeptember 10, 2017

Bristol-Myers Squibb Company has announced results from the Phase 3 CheckMate -214 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC), including data on key subgroups. With a minimum follow-up of 17.5 months, Opdivo in combination with Yervoy reduced the risk of death 37% [HR 0.63; 99.8% CI: 0.44 to 0.89; P < 0.0001] compared with sunitinib, the current standard of care, in an interim analysis of overall survival (OS) in intermediate- and poor-risk patients, the co-primary endpoint. The median OS had not yet been reached for the combination and was 26 months for sunitinib (95% CI: 22.1 to NA). Results from CheckMate -214 were presented during Presidential Symposium at the ESMO 2017 Congress.

Abemaciclib Initial Therapy Improves Outcome in Endocrine-sensitive Advanced Breast Cancer

Eli Lilly LogoSeptember 10, 2017

The results of the MONARCH 3 trial by Eli Lilly, presented at the ESMO 2017 Congress, showed that adding the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib to endocrine therapy improved progression-free survival compared to endocrine therapy alone in the total study population. While most women had substantial benefit from the addition of abemaciclib as initial treatment, around one-third of women reportedly may not need a CDK 4/6 inhibitor as initial treatment.

Roche announces phase III study results of Zelboraf for adjuvant treatment of BRAF V600 mutation-positive melanoma

Roche logoSeptember 11, 2017

Roche has announced data for the phase III BRIM8 study, which was designed to investigate the efficacy and safety of Zelboraf® (vemurafenib) in the adjuvant (after surgery) treatment of people with completely resected, BRAF V600 mutation-positive melanoma. The study assessed two cohorts; stage IIC-IIIB (cohort 1) and stage IIIC (cohort 2) melanoma patients. The study did not meet its primary endpoint of significantly reducing the risk of recurrence (disease-free survival; DFS) in patients with stage IIIC melanoma (cohort 2); however, a 46% reduction in recurrence risk was observed in stage IIC-IIIB patients (cohort 1). The safety profile was consistent with that seen in previous studies of Zelboraf in advanced melanoma.

Novartis Phase III study demonstrates adjuvant Tafinlar® + Mekinist® reduced the risk of disease recurrence by 53% in patients with resected BRAF V600 mutation-positive melanoma

Novartis logo - luca dezzaniSeptember 11, 2017

Novartis has announced results from a Phase III study of 870 patients with stage III BRAF V600E/K mutation-positive melanoma after complete surgical resection treated with the combination of Tafinlar® (dabrafenib) + Mekinist® (trametinib). Findings from the COMBI-AD study, which met its primary endpoint, found a statistically significant 53% reduction in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy versus placebo (HR [hazard ratio]: 0.47 [95% CI (confidence interval): 0.39-0.58]; median not reached vs. 16.6 months, respectively; p<0.001), with no new safety signals reported. Results of the study were presented during the Presidential Symposium at ESMO.

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