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Trial Results

KEYTRUDA Monotherapy Met Primary Endpoint in Phase III Study

April 16, 2018

Merck announced that the pivotal Phase III KEYNOTE-042 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer met its primary endpoint of overall survival. KEYNOTE-042 is an international, randomized, open-label Phase III study investigating KEYTRUDA monotherapy compared to standard-of-care platinum-based chemotherapy in patients with locally advanced or metastatic PD-L1 positive (TPS ≥1 percent) NSCLC. Patients had no EGFR or ALK genomic tumor aberrations and had not previously received systemic therapy for advanced disease. The primary endpoint is OS with TPS of ≥50 percent, ≥20 percent and ≥1 percent, which were assessed sequentially. The secondary endpoints are PFS and objective response rate (ORR). The study enrolled 1,274 patients randomized 1:1 to receive either KEYTRUDA (200 mg fixed dose every three weeks). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC.

Upadacitinib Meets all Primary Endpoints in Rheumatoid Arthritis Study
AbbVie announced positive top-line results from the Phase III SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remissionb versus placebo. All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week). SELECT-COMPARE is a Phase III, multicenter, randomized, double-blind, study designed to evaluate the safety and efficacy of upadacitinib compared to placebo and adalimumab in adult patients with moderate-to-severe Rheumatoid Arthritis. The study showed that at week 12, 71 percent of patients receiving an oral once-daily dose of upadacitinib 15 mg achieved an ACR20 response, compared with 36 percent of patients receiving placebo. A significantly higher proportion of patients receiving upadacitinib achieved clinical remission compared with placebo at week 12 (29 percent versus 6 percent, respectively).The trial is ongoing and includes a 48 week randomized, double-blind treatment period followed by a long-term extension study of up to five years.

Therapix Biosciences Announces Topline Results of Phase IIa
TEL AVIV announced topline results from its investigator-initiated Phase IIa study, suggesting that THX-110 [which is a combination of dronabinol (Delta-9-tetrahydracannabinol) and palmitoylethanolamide (PEA)] significantly improved symptoms over time in adult subjects with Tourette syndrome. The study was a single-arm, open-label trial, in which each subject both received one daily treatment of the drug via oral administration and was followed-up for a period of 12 weeks. Sixteen subjects participated in the study and received THX-110 at Yale University. The study showed that these 16 subjects with medication-refractory TS had a reduction of tic symptoms (paired t-test: YGTSS-TTS mean difference (mean +/- SD) =7.9+/-8.4, t= 3.7, df=15, p=0.002) from baseline (YGTSS-TTS: 38.4 +/- 8.3) to endpoint (YGTSS-TTS: 30.5 +/- 10.9). This resulted in an average tic reduction of 21 percent across the entire sample. Improvement over time with treatment was also observed when generalized linear models were used to analyze repeated measures data on the YGTSS-TTS. THX-110 demonstrated no significant effects on comorbidity.

Pfizer Stops Phase III Trial of Axitinib
Pfizer announced that the Phase III ATLAS trial evaluating INLYTA (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy was recommended to stop the trial at a planned interim analysis due to futility. The recommendation was based on the study failing to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS) for patients treated with INLYTA compared with patients treated with placebo. Although NLYTA has had a significant impact on the treatment of patients with advanced RCC worldwide in its currently approved indications, no new safety signals were observed. ATLAS (A Randomized Double-Blind Phase III Study of Adjuvant Axitinib Versus Placebo in Subjects at High Risk of Recurrent RCC)(NCT01599754) is a global, multicenter, randomized double-blind Phase III trial that investigated the clinical efficacy and safety of adjuvant INLYTA (5 mg twice daily) versus placebo in patients (n=724) at high risk of recurrent RCC following nephrectomy. Patients were dosed up to three years (for a minimum of one year) in the study and the primary endpoint was disease-free survival (DFS).