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New Hope For AZN's Old Drug, More About BMY's Opdivo, IMDZ On Watch


Today's Daily Dose brings you news about Array's encouraging results from phase III melanoma study; AstraZeneca's newfound hope in Imfinzi in lung cancer setting; Blueprint's ongoing phase I trial of BLU-554 in advanced hepatocellular carcinoma; Bristol-Myers' CheckMate -238 trial and Immune Design's soft tissue sarcoma trial results.

Read on...

Array BioPharma (ARRY) and Pierre Fabre, on Saturday, announced encouraging results from Part 2 of a phase III study evaluating Binimetinib and Encorafenib in patients with BRAF-mutant advanced, unresectable or metastatic melanoma, dubbed COLUMBUS.

The primary analysis of Part 2 compared progression free survival (PFS) in patients treated with Binimetinib 45 mg twice daily plus Encorafenib 300 mg daily to patients treated with Encorafenib 300 mg daily as a single agent.

The median PFS for patients treated with the combination of Binimetinib and Encorafenib was 12.9 months compared to 9.2 months for patients treated with single agent Encorafenib.

The Company submitted two New Drug Applications to the FDA for Binimetinib and Encorafenib in advanced melanoma in July of this year.

In addition, Array's European partner, Pierre Fabre, announced on August 28, 2017, that the European Medicines Agency has validated the review of the MAAs for Binimetinib and Encorafenib.

ARRY closed Friday's trading at $10.98, up 6.91%.

AstraZeneca plc (AZN), which suffered a setback for its immunotherapy drug Imfinzi in lung cancer setting in July of this year, has now reasons to cheer, thanks to encouraging PACIFIC trial data.

The PACIFIC trial is a phase III study of Imfinzi as sequential treatment in patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy.

According to the trial results, Imfinzi improved progression-free survival by more than 11 months compared to standard of care following chemoradiation therapy (CRT), and is the first medicine to show superior PFS in this setting. The progression free survival was 16.8 months in patients treated with Imfinzi compared to 5.6 months in the placebo arm.

The July setback refers to the failed MYSTIC trial, a phase III study of Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer.

Imfinzi received accelerated approval from the FDA in May of this year to treat people with advanced urothelial carcinoma who have already had chemotherapy.

AZN closed Friday's trading at $32.25, up 1.13%.

Blueprint Medicines Corp.'s (BPMC) updated data from its ongoing Phase 1 clinical trial of BLU-554 in patients with advanced hepatocellular carcinoma has demonstrated a 16 percent objective response rate in patients with FGFR4-driven hepatocellular carcinoma. Also, 49 percent of patients with FGFR4-driven hepatocellular carcinoma had radiographic tumor reduction.

BLU-554 was well-tolerated and most adverse events reported by investigators were Grade 1 or 2, according to the Company.

Blueprint Medicines plans to continue to enroll and follow the cohort of patients with FGFR4-driven HCC in the ongoing Phase 1 clinical trial to further evaluate the safety and clinical activity of BLU-554 in this population. In addition, the Company plans to initiate an additional cohort in this clinical trial in the first quarter of 2018 to evaluate BLU-554 in TKI-naïve patients with FGFR4-driven HCC.

BPMC closed Friday's trading at $52.28, down 1.45%.

Bristol-Myers Squibb Co.'s (BMY) blockbuster immunotherapy drug Opdivo 3 mg/kg resulted in a significant improvement in recurrence-free survival compared to its own Yervoy 10 mg/kg in patients with stage IIIb/c or stage IV melanoma following complete surgical resection in an ongoing phase III study called CheckMate -238.

In the CheckMate -238 study, Opdivo decreased the risk of disease recurrence by 35% compared to Yervoy. The 18-month recurrence-free survival rates for the Opdivo and Yervoy groups, respectively, were 66.4% and 52.7%. Opdivo is the first PD-1 to significantly improve RFS and the only I-O agent to demonstrate superior results, including better tolerance, as compared to an active control, in the treatment of adjuvant melanoma, according to the Company.

In another phase III trial, dubbed CheckMate -214, Opdivo in combination with Yervoy reduced the risk of death by 37% versus Pfizer Inc.'s (PFE) Sutent, the standard of care, in patients with previously untreated advanced or metastatic renal cell carcinoma.

The combination also significantly improved overall survival in all randomized patients, and demonstrated a 42% objective response rate in intermediate- and poor-risk patients.

Grade 3/4 adverse events experienced by 46% of patients in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg combination arm and 64% in the Sutent arm, the Company added.

In the first half of 2017, Opdivo sales were $2.32 billion; Yervoy sales were $652 million and Sutent sales were $529 million.

BMY closed Friday's trading at $62.62, down 0.35%.

An updated analysis of Ipsen (IPSEY.OB) and Exelixis Inc.'s (EXEL) phase II trial of Cabozantinib versus Pfizer Inc.'s (PFE) Sutent in previously untreated advanced renal cell carcinoma has yielded encouraging results.

The trial, dubbed CABOSUN, consistently show that Cabozantinib provided a statistically significant decrease in the rate of disease progression or death compared to Sutent, a current standard of care - potentially offering a new treatment option for physicians to treat patients in the first-line advanced renal cell carcinoma setting, noted the Company.

The median overall survival was 26.6 months for patients receiving Cabozantinib and 21.2 months for those receiving Sutent. The updated overall survival (OS) analysis showed a favorable trend for patients randomized to Cabozantinib compared to Sutent that was not statistically significant.

Exelixis filed a supplemental New Drug Application based on the CABOSUN data with the FDA for Cabozantinib as a treatment for previously untreated advanced RCC on August 16, 2017. Ipsen also submitted to EMA the regulatory dossier for Cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017, and the application has been validated.

Exelixis netted $88 million in Cabozantinib franchise product revenue in Q2, 2017, up from $68.9 million in Q1, 2017.

EXEL closed Friday's trading at $25.97, up 1.21%.

An interim analysis of Immune Design's (IMDZ) phase II trial evaluating the combination of investigational CMB305 and Roche's TECENTRIQ in NY-ESO-1 expressing soft tissue sarcoma patients has shown that there was greater clinical benefit and immune response in the combination arm compared to those receiving TECENTRIQ alone.

The ongoing phase II trial has enrolled 88 soft tissue sarcoma patients.

The interim analysis of 36 patients in the trial showed that the Disease Control Rate was 61% in the CMB305 plus Tecentriq arm compared to 28% in the Tecentriq alone arm. The Median Progression Free Survival was 2.6 months for the combination arm Vs 1.4 months for the Tecentriq alone arm. The Time to Next Treatment was 9 months for patients treated with CMB305 plus Tecentriq whereas it was 6.3 months for patients treated with Tecentriq alone.

Based on the full study population, the Disease Control Rate was 57% for the combination arm and 38% for Tecentriq alone arm.

IMDZ closed Friday's trading at $10.20, down 6.42%.

by RTTNews Staff Writer

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