Publications by authors named "A G Manikhas"
Article Synopsis
- The NATALEE trial evaluated the effectiveness of ribociclib in combination with nonsteroidal aromatase inhibitors (NSAI) compared to NSAI alone over three years for treating HR+/HER2- early breast cancer patients.
- The study involved 5,101 patients who were randomized to receive either ribociclib plus NSAI or NSAI alone, with the primary focus on invasive disease-free survival (iDFS).
- Results showed that ribociclib plus NSAI significantly improved iDFS, with 90.7% of patients remaining disease-free compared to 87.6% for those on NSAI alone, while safety profiles remained consistent with no new safety concerns.
Purpose: Dr Reddy's Laboratories Trastuzumab (DRL_TZ) is a biosimilar to Herceptin under development. The present study was conducted to evaluate efficacy, safety, pharmacokinetics (PKs), and immunogenicity of DRL_TZ in comparison with the reference medicinal product (RMP) along with concomitant weekly paclitaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).
Methods: This was a randomized, double-blind study in female patients with HER2-positive MBC, randomly assigned in a 1:1 ratio to receive either DRL_TZ or the RMP, that is, an innovator product sourced from the European region, along with additional chemotherapy, as first-line treatment for up to 24 weeks.
Background: The Phase 3 CT-P6 3.2 study demonstrated equivalent efficacy and comparable safety between CT-P6 and reference trastuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive early breast cancer after up to 3 years' follow-up.
Objective: To investigate long-term survival with CT-P6 and reference trastuzumab.
Background: The TROIKA trial established that HD201 and trastuzumab were equivalent in terms of primary endpoints (total pathological complete response) following neoadjuvant treatment. The objective of the present analysis was to compare survival outcomes and final safety.
Methods: In the TROIKA trial, patients with ERBB2-positive early breast cancer were randomized and treated with either HD201 or the referent trastuzumab.
Purpose: Resistance to endocrine therapy poses a major clinical challenge for patients with hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). We present the preplanned 24-month final overall survival (OS) results, alongside updated progression-free survival (PFS), and objective response rate (ORR) results.
Methods: nextMONARCH is an open-label, controlled, randomized, Phase 2 study of abemaciclib alone or in combination with tamoxifen in women with endocrine-refractory HR + , HER2- MBC previously treated with chemotherapy.