Trial Results

GT Biopharma Announces Preliminary Clinical Results From Interim Review of Phase I/II Trial

June 18, 2018

GT Biopharma announced preliminary clinical data taken from an interim review, or snapshot, of the OXS-1550 Phase I/II trial for patients with relapsed/refractory B-cell lymphoma or leukemia. OXS-1550 is being evaluated in an open-label, two-stage, investigator-led, Phase I/II trial. The trial has two arms including patients diagnosed with relapsed/refractory B-cell lymphomas (NHL) and leukemias (ALL). 18 patients have been enrolled to date, including 12 NHL and six ALL patients. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients. At the interim review more than 50 percent of patients (seven of 13) exhibited a clinical benefit, defined as stable disease plus partial response or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial response (PR) and five demonstrated stable disease (SD). The efficacy signal was most prominent in ALL patients with 75 percent (three of four) exhibiting clinical benefit including one CR, one PR and one SD. Adverse events were mostly grade 1 and 2 and reversible. One patient had a grade 4 low platelet count, two patients had a grade 3 increase in liver function tests, or LFTs, and one patient had a grade 3 capillary leak.

Allergan Announces Positive Results for Migraine Clinical Trial
Allergan announced positive results from CGP-MD-01, a Phase IIb/III clinical trial evaluating the efficacy, safety, and tolerability of orally administered atogepant. Study CGP-MD-01 is a Phase IIb/III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The primary efficacy endpoint was the change from baseline in mean monthly migraine/probable migraine (MPM) headache days across the 12-week treatment period. All active treatment arms of atogepant met the primary endpoint across all doses and dose regimens, with a statistically significant reduction from baseline in monthly migraine/probable migraine (MPM) headache days in patients with episodic migraine treated with atogepant compared with placebo for 12 weeks. In study CGP-MD-01 834 U.S. adult patients were randomized (2:1:2:1:2:1) to placebo, 10-mg QD, 30-mg QD, 30-mg BID, 60-mg QD, and 60-mg BID respectively, and treated under double blind conditions 12 weeks for the prevention of episodic migraine. Efficacy analyses were based on the modified ITT (mITT) population of 795 patients. All active treatment groups demonstrated a statistically significant reduction from baseline in the primary efficacy parameter (10 mg QD vs placebo, p=0.0236; 30 mg QD vs placebo, p=0.0390; 60 mg QD vs placebo, p=0.0390; 30 mg BID vs placebo; p=0.0034, 60 mg BID vs placebo, p=0.0031). The most common adverse events were nausea, fatigue, constipation, nasopharyngitis, and urinary tract infection.

Seattle Genetics Announces First Patient Dosed in Phase II Trial for Metastatic Cervical Cancer
Seattle Genetics announced dosing of the first patient in the Phase II innovaTV 204 clinical trial evaluating the efficacy, safety and tolerability of tisotumab vedotin as monotherapy for patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target Tissue Factor antigen on cancer cell surfaces and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells. The Phase II innovaTV 204 study (also known as GCT1015-04) is a global, multicenter, single arm trial that will enroll approximately 100 patients with recurrent and/or metastatic (2nd and 3rd line) cervical cancer who progressed on or relapsed after treatment with platinum-based chemotherapy used alone or in combination with bevacizumab (Avastin). Patients will be treated with single-agent tisotumab vedotin every three weeks. The primary endpoint of the trial is objective response rate as assessed by independent review. Key secondary endpoints include duration of response, progression-free survival, overall survival, safety and tolerability.

ViiV Healthcare Announces Positive Results for Duo-Combo HIV Treatment
ViiV Healthcare announced positive headline results from its Phase III GEMINI study programme. The studies (GEMINI-1 and GEMINI-2) are designed to evaluate the safety and efficacy of a two-drug regimen (2DR) of dolutegravir and lamivudine compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment naïve HIV-1 infected adults with baseline viral loads less than 500,000 copies per ml. GEMINI 1 (204861) and GEMINI 2 (205543) are duplicate, Phase III, randomized, double-blind, multicenter, parallel group, non-inferiority studies. The studies together include approximately 1,400 men and women living with HIV and are being conducted at research centers in Europe, Central and South America, North America, South Africa and Asia Pacific. The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50 copies per milliliter (c/mL), a standard measure of HIV control, at Week 48. The safety results for the 2DR of dolutegravir and lamivudine were consistent with the product labelling for the medicines. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance.