Mundipharma’s AffIRM study, the largest ever real-world flutiform study involving over 2,500 patients, has shown that the proportion of patients with well-controlled asthma more than doubled 12 months after switching to flutiform pMDI (pressurised metered dose inhaler) compared with baseline. The mean total Asthma Control Test score also increased from 16.3 to 20.4.
GlaxoSmithKline and Innoviva have announced positive results from the Salford Lung Study in asthma. The study, which reported headline results in May, showed that that initiation of once-daily Relvar Ellipta (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) 92/22mcg or 184/22mcg was superior to usual care in achieving a consistent improvement in patient’s asthma control over the 12 month study duration, measured by the Asthma Control Test (ACT), compared with patients who continued to take their usual care medicines. Statistically significant findings were also seen at 12, 40 and 52 weeks.
AstraZeneca presented new evidence on budesonide/formoterol from INCONTROL 1, a first of its kind post-hoc analysis of a large pooled data set of Phase III chronic obstructive pulmonary disease (COPD) studies. INCONTROL 1 investigated patient characteristics that may interact with the treatment response to a combination of budesonide (inhaled corticosteroid or ICS) and formoterol (long-acting beta agonist or LABA), versus formoterol alone. In COPD patients who have experienced one or more exacerbations in the previous year, maintenance treatment with budesonide/formoterol 160/4.5 μg offered clinically relevant reductions in exacerbations compared with formoterol 4.5 μg alone in patients with a PBE of 0.1 x109 cells/L or greater.
Amgen and Allergan announced data from a Phase III study evaluating the efficacy and safety of ABP 980, a Herceptin (trastuzumab) biosimilar, compared with the originator product in patients with HER2-positive early breast cancer. Results from the study support ABP 980 as a trastuzumab biosimilar, showing 48 percent and 40.5 percent of patients in the ABP 980 arm and trastuzumab arm, respectively, achieved pathologic complete response. risk difference and risk ration of pathologic complete response were 7.3 percent (90 percent CI: 1.2, 13.4) and 1.19 (90 percent CI: 1.033, 1.366) respectively.
AstraZeneca presented PFS details of the PACIFIC study (Imfinzi in stage III/unresectable non-small cell lung cancer that has not progressed after chemoradiotherapy). The company called the 11+ months increase in PFS with Imfinzi versus placebo (HR=0.52, CI 0.42=0.65, p<0.0001) is “impressive”, along with the secondary end-points of the duration of response (28.4 months versus 16.0 months, objective response rate and time to distant metastases).