Writing Portfolio
The ABIS Group
Assistant Editor
Phase III STARDOM2 trial shows tramadol-celecoxib noninferior to tramadol for cumulative pain scores after abdominal hysterectomy
The Phase III STARDOM2 trial published in the European Journal of Pain found the co-crystal formulation of tramadol-celecoxib was noninferior to tramadol for cumulative pain scores after an abdominal hysterectomy. Richard Langford of The London Clinic and colleagues enrolled 1,355 patients with moderate-to-severe pain following abdominal hysterectomy who were randomized to receive oral CTC 100 mg twice-daily, CTC 150 mg twice-daily, CTC 200 mg twice-daily, immediate-release tramadol 100 mg four-times-daily or placebo. They found more recipients of CTC 200 mg responded to treatment, determined as a 50% reduction from baseline in pain intensity. Additionally, CTC 200-mg and 150-mg recipients were less likely than placebo recipients to require rescue medication in four hours. Overall, 32% of patients reported a treatment-emergent adverse event.
Phase I/II trial shows AstraZeneca's MEDI5752 plus chemotherapy demonstrates ORR of 50% in NSCLC
Phase I/II data presented at the ESMO Congress showed AstraZeneca's MEDI5752, a bispecific that targets PD-1 and CTLA-4, may rival Merck & Co.'s Keytruda (pembrolizumab) in non-small cell lung cancer. Among 20 patients treated with 1,500 mg of MEDI5752, the objective response rate was 50%. Among a subset of nine patients with PD-L1 levels lower than 1%, the ORR was 55.6%. In the Keytruda and chemo arm, ORR was 47.6% for the overall group of 21 patients and 30% for the 10-patient PD-L1-low subgroup. Progression-free survival was slightly more than six months longer for the bispecific arm in the overall patient population and almost 4.5 months greater in the PD-L1 subset. At the 1,500-mg dose, 70% of treated patients experienced grade 3, treatment-related adverse events and discontinued treatment. As a result, the company tested a 750-mg version in a single-arm cohort of 50 patients, finding the ORR at the lower dose was 44%.
