2023
-1
archive,date,bridge-core-1.0.4,ajax_fade,page_not_loaded,,qode-content-sidebar-responsive,qode-child-theme-ver-1.0.0,qode-theme-ver-18.0.9,qode-theme-bridge,qode_header_in_grid,bridge-child,wpb-js-composer js-comp-ver-5.7,vc_responsive
 

October 2023

In this phase 2 study, patients with advanced NSCLC harbouring sensitizing EGFR and T790M mutations in plasma at progression from ≥one 1G/2G TKI were treated with 80 mg of Osimertinib daily until progression. During the treatment, ctDNA clearance at Cycle 3 (C3) showed improved PFS (median 15.2 months vs. 6.0 months, HR 0.37, 95% CI 0.23–0.60) and OS (median 34.0 months vs. 17.2 months, HR 0.42, 95% CI 0.24–0.72) compared to patients who did not clear ctDNA at C3. The ctDNA baseline load as well as dynamics can be prognostic, and blood testing for T790M can be used as a surrogate marker to guide Osimertinib use. (Ref: Ang YLE, et al. Cancers. October 16, 2023)

#oncologyresearch #clinicalresearch #clinicaldevelopment

In the phase 3 PROpel trial, a significant improvement in overall survival is observed for olaparib with abiraterone compared to placebo with abiraterone in patients with mCRPC.  The improvement observed was primarily attributable to patients with BRCA mutation. ( Ref: Saad F, et al. Lancet Oncol. Sep 12, 2023)

#oncologyresearch #clinicalresearch #clinicaldevelopment

In the phase 2 CAPRI  trial, patients with recurrent, platinum-sensitive BRCA1/2 mutated or homologous recombination (HR) deficient high-grade serous ovarian cancer (HGSOC) and clinically benefited from PARPi before progression, treated with ceralasertib (ATR inhibitor) and olaparib (PARP inhibitor) showed ORR of 50% (95% confidence interval, 0.15-0.72). ATR inhibition re-sensitizes PARPi-resistant cells to PARP inhibition and has an apparent synergistic effect with PARP inhibition. Grade 3/4 toxicities were 38%: anemia (15%), thrombocytopenia (23%), and neutropenia (8%). The combination was tolerable and showed activity in patients who progressed with PARPi as the penultimate regimen. (Ref: Wethington SL, et al. Clin Cancer Res. August 1, 2023)

#oncologyresearch #clinicalresearch #clinicaldevelopment

In the KEYNOTE-B61 phase 2, single-arm study, patients with previously untreated stage IV non-clear-cell renal cell carcinoma treated with pembrolizumab plus lenvatinib showed a confirmed objective response (49%; 95% CI 41-57), including confirmed complete response (6%) and partial response (44%). The most common Grade 3-4 treatment-related adverse events were hypertension (23%), proteinuria (4%), and stomatitis (4%). (Albiges L, et al. Lancet Oncol. August, 2023)

#oncologyresearch #clinicalresearch #clinicaldevelopment

In single-arm, phase 2 RAGNAR study, treatment with erdafitinib (selective pan-FGFR tyrosine kinase inhibitor) showed clinical benefit in the tumour-agnostic setting in patients with advanced solid tumours with susceptible FGFR alterations who have exhausted other treatment options. An objective response was observed in 64 (30% [95% CI 24–36]) of 217 patients across 16 distinct tumour types. The most commonly occurring serious treatment-related adverse events (grade 3 or higher) were stomatitis (2%) and diarrhoea (1%). (Pant S, et al. Lancet Oncol. August 2023)

In the Phase III study in 708  patients with HR–positive, HER2-negative advanced breast cancer who progressed during or after aromatase inhibitor therapy, the combination of AKT inhibitor capivasertib and fulvestrant showed significantly longer progression-free survival than with fulvestrant alone, both in the overall population (HR: 0.60) and among patients with AKT pathway–altered tumors (HR: 0.50). Overall survival was improved with the combination (HR: 0.74). (Ref: Turner NC, et al. N Engl J Med. June 1, 2023)

#oncologyresearch #clinicalresearch #clinicaldevelopment

In a phase 3 RUBY trial, dostarlimab combined with chemotherapy (carboplatin and paclitaxel) significantly increased progression-free survival as compared to placebo, with a substantial benefit in the dMMR–MSI-H population in patients with primary advanced stage III or IV or first recurrent endometrial Cancer. More severe and serious adverse events occurred in the dostarlimab group than in the placebo group. The safety profile of the combination was generally consistent with the known profiles of the individual drugs in the regimen. (Ref: Mirza MR, et al. N Engl J Med. March 27, 2023)

#oncologyresearch #clinicalresearch #clinicaldevelopment