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Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of June 29, 2015

Avalanche Biotechnologies reported results of a phase IIa study of AVA-101 for wet age-related macular degeneration (wet AMD). The study enrolled 32 subjects aged 55 or older with wet AMD and randomized them to an AVA-101 treatment group (n=21) or a control group (n=11). Subjects in both groups received two ranibizumab injections at day zero and week four, and ranibizumab rescue therapy was allowed according to pre-specified criteria beginning at week eight. In the study, best corrected visual acuity (BCVA) mean change from baseline showed a difference of 11.5 letters between the treatment (+2.2 letters) and control (-9.3 letters) groups (95% CI, 2.3-20.7 letters). Additionally, a significant number of AVA-101 treated subjects (42.9%) improved or maintained stable vision with two or fewer rescue injections compared with subjects in the control group (9.1%). Importantly, BCVA improvement of at least 10 letters with two or fewer rescue injections was observed in 23.8% of treated subjects and 0% of subjects in the control group. No serious adverse events related to AVA-101 were observed. These data will help inform the design of Avalanche’s phase IIb AVA-101 study, which the company plans to conduct at multiple centers in the U.S. later this year.

Boehringer Ingelheim issued results of a phase III study of afatinib v. erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. Significantly more patients treated with afatinib were still alive at one year compared to those treated with erlotinib (36.4 v. 28.2%). The updated analysis of PFS confirmed a significant reduction in the risk of cancer progression by 19% in patients treated with afatinib compared with erlotinib. The delay in cancer progression seen with afatinib treatment was accompanied by improved control of cancer-related symptoms: a higher proportion of patients treated with afatinib reported improvement in cough (43.4 v. 35.2%), shortness of breath (51.3 v. 44.1%) and overall well-being/quality-of-life (35.7 v. 28.3%) compared with erlotinib. The rate of severe adverse events was similar between afatinib and erlotinib treatment arms (57.1 v. 57.5%). Afatinib is approved in more than 50 countries for the first-line treatment of distinct types of EGFR mutation-positive NSCLC. Afatinib is not approved for use in patients with SCC of the lung. The complete results from this study will be the basis for global regulatory submissions later this year.

Genentech released results of a phase II study of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for HER2-positive early breast cancer (eBC). The randomized, multicenter, international study enrolled 417 people with newly diagnosed HER2-positive, operable, locally advanced or inflammatory eBC. Participants were randomized to one of four study arms and received four cycles (12 weeks) of neoadjuvant treatment followed by surgery and a year of adjuvant treatment with Herceptin plus chemotherapy. Both progression-free survival (PFS) and disease-free survival (DFS) were evaluated at three years. The results suggested that people who received the Perjeta regimen prior to surgery were 31% less likely to experience disease worsening, recurrence or death (PFS HR=0.69; 95% CI, 0.34–1.40) compared to those who received Herceptin and chemotherapy. People treated with the Perjeta regimen also were 40% less likely to experience disease recurrence or death (DFS HR=0.60; 95% CI, 0.28–1.27). The results suggested that people who achieved pathological complete response (pCR; no tumor tissue detectable at the time of surgery in the affected breast and local lymph nodes) were more likely across all arms of the study to be alive and disease-free at three years (PFS HR=0.54; 95% CI, 0.29–1.00; DFS HR=0.68; 95% CI, 0.36–1.26). It previously was reported that the Perjeta regimen significantly increased the number of people who achieved pCR compared to Herceptin and docetaxel chemotherapy (39.3% v. 21.5%). In 2013, the FDA granted accelerated approval of the Perjeta regimen for neoadjuvant treatment in people with high-risk, HER2-positive eBC. Roche recently submitted a MAA to the EMA for the Perjeta regimen as a neoadjuvant treatment for people with HER2-positive eBC.

Novartis issued results of two phase IIIb studies of Cosentyx (secukinumab) for psoriasis of the palms, soles of feet and nails. Both studies were double-blind, randomized, placebo-controlled, parallel-group studies. GESTURE enrolled 205 subjects with moderate to severe nonpustular palmoplantar psoriasis randomized 1:1:1 to receive either Cosentyx 300mg, Cosentyx 150mg or placebo subcutaneously for 76 weeks. TRANSFIGURE enrolled 198 patients with chronic moderate to severe plaque psoriasis, including significant nail involvement, randomized 1:1:1 to receive either Cosentyx 300mg, Cosentyx 150mg or placebo subcutaneously up to week 76. In GESTURE, Cosentyx was superior to placebo at week 16 in achieving clear or almost clear palms and soles as assessed using the Palmoplantar Investigator’s Global Assessment (ppIGA) (33.3% Cosentyx 300mg [P<0.0001], 22.1% Cosentyx 150mg [P<0.001], 1.5% placebo). Similarly, in TRANSFIGURE, Cosentyx was superior to placebo at week 16, as assessed by mean improvement (decrease) in the fingernail NAil Psoriasis Severity Index (NAPSI) compared to baseline (-45.3% Cosentyx 300mg [P<0.0001], -37.9% Cosentyx 150mg [P<0.0001], -10.8% placebo). Cosentyx is approved by the FDA for moderate to severe plaque psoriasis in adults.

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