AMGN Finds New Use For Old Drug, NLNK Disappointed, ECYT Cuts Workforce

(RTTNews) - Today's Daily Dose brings you news about Amgen's multiple myeloma trial results with XGEVA; Merck's findings from Cohort 1 of phase 2 registrational trial of KEYTRUDA in gastric cancer patients; Prima BioMed's phase II results of IMP321 in breast cancer; TG Therapeutics' phase III study results of TG-1101 in patients with previously treated high risk Chronic Lymphocytic Leukemia and NewLink's disappointment in phase II trial of Indoximod in breast cancer.

Read on...

Amgen (AMGN) on Sunday announced that its drug XGEVA has proven to be non-inferior to Zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma in a phase III trial. XGEVA-treated patients also had a significantly lower rate of renal adverse events compared to Zometa in the study.

Amgen's XGEVA is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, and for the treatment of giant cell tumor of the bone. XGEVA is currently not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

Zoledronic acid is marketed by Novartis under the trade names Zometa, Zomera, Aclasta and Reclast. Novartis' Zometa is indicated for the treatment of bone complications in patients with multiple myeloma.

Amgen is seeking to expand the currently approved XGEVA indication to include patients with multiple myeloma, and has made regulatory submissions in the U.S. and EU for the same.

XGEVA recorded sales of $1.53 billion in 2016, up 9% over the prior year. Novartis' Zometa went off patent in 2013.

AMGN closed Friday's trading at $159.15, up 1.86%.

Shares of Endocyte Inc. (ECYT) plunged over 30% on Friday, following its plans to trim its workforce by approximately 40 percent and end the clinical development of its drug candidate EC1456, under phase I development for ovarian cancer.

The Company noted that an assessment of the study did not yield the level of clinical activity necessary to support continued advancement of EC1456 as a result of which it has stopped enrollment in the phase I trial.

Endocyte has also stopped enrollment in its phase I trial of another investigational drug EC1169 in taxane-naïve metastatic castration resistant prostate cancer (mCRPC) patients. But the Company will focus on the cohort of taxane-exposed, metastatic castration-resistant prostate cancer (mCRPC) patients, for which a top-line efficacy assessment of the expansion phase of this phase 1 trial is expected before the end of 2017.

The Company added that the reduction in work force is to better focus its resources on the company's highest value opportunities, while maintaining key capabilities.

ECYT closed Friday's trading at $1.91, down 30.04%.

Merck's (MRK) phase 2 registrational trial of KEYTRUDA as monotherapy in previously-treated patients with advanced gastric or gastroesophageal junction adenocarcinoma has shown meaningful response rates in heavily pre-treated patients, who have historically faced poor outcomes.

The findings from Cohort 1 of the trial showed an overall response rate of 11.6 percent in patients treated with KEYTRUDA who had received two or more prior lines of treatment, with higher response rates among patients with PD-L1 positive tumors.

Merck's supplemental biologics license application seeking approval of Keytruda for the treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have undergone at least two courses of chemotherapy is under priority review, with a decision date set for September 22, 2017.

Keytruda brought home sales of $1.40 billion in 2016, up 148% over the prior year.

MRK closed Friday's trading at $65.47, up 0.32%.

NewLink Genetics Corp.'s (NLNK) phase II trial of Indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer did not meet its pre-specified endpoints.

The trial failed to meet the pre-specified endpoints of progression-free survival, overall survival or objective response rate.

NLNK closed Friday's trading at $12.59, down 1.25%.

Pfizer Inc. (PFE) has reported encouraging results from phase II study of Talazoparib in patients with germline (inherited) BRCA1/2-positive (gBRCA+) advanced breast cancer.

The study, dubbed ABRAZO, consisted of two Cohorts.

Cohort 1 consisted of 49 patients who previously responded to platinum-based chemotherapy and subsequently developed disease progression. Cohort 2 consisted of 35 patients who developed disease progression following at least three lines of non-platinum-based therapy.

The primary endpoint of the ABRAZO trial was objective response rate, or ORR, by independent radiology review.

A 21% ORR was observed in Cohort 1 and a 37% ORR was observed in Cohort 2.

A phase III study, evaluating Talazoparib against protocol-specific physician's choice of chemotherapy in patients with advanced and/or metastatic gBRCA+ breast cancer who have received zero to three prior chemotherapy regimens for advanced disease, dubbed EMBRACA, is underway.

PFE closed Friday's trading at $32.54, down 0.52%.

Prima BioMed Ltd.'s (PBMD) cancer drug candidate IMP321 (LAG-3Ig) has demonstrated positive safety and efficacy qualities in a phase II breast cancer trial.

The phase II trial, dubbed AIPAC, evaluated IMP321 in hormone receptor-positive metastatic breast cancer patients against placebo as adjunctive to first-line weekly chemotherapy, paclitaxel.

According to the Company, IMP321 in combination with paclitaxel showed an encouraging disease control rate of 87%.

PBMD closed Friday's trading at $2.56, up 1.59%.

Rexahn Pharmaceuticals Inc.'s (RNN) interim update on the safety and efficacy of RX-3117 monotherapy in an ongoing Phase IIa clinical trial has revealed an increased progression free survival and evidence of tumor shrinkage in patients with metastatic bladder cancer resistant to Gemcitabine who had failed on multiple prior treatments.

Based on the positive preliminary efficacy results from Stage 1, the Company has begun the second stage of the phase IIa study.

RNN closed Friday's trading at $4.19, up 4.75%.

TG Therapeutics Inc.'s (TGTX) phase III study of TG-1101 plus Johnson & Johnson (JNJ) drug IMBRUVICA in patients with previously treated high risk Chronic Lymphocytic Leukemia has met its primary endpoint.

In the study, dubbed GENUINE, TG-1101 plus IMBRUVICA increased overall response rate by more than 70% over ibrutinib alone.

The combination of TG-1101 and IMBRUVICA resulted in 19% Minimal Residual Disease negativity compared to 2% for IMBRUVICA alone.

The Company is planning to file for accelerated approval of TG-1101 later this year.

TGTX closed Friday's trading at $3.85, up 17.37%.