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31 Oct

Posted at 05:30h in Blogs by

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

30 Sep

Posted at 12:02h in Blogs by

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

07 Sep

Posted at 09:24h in Blogs by

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

16 Aug

Posted at 05:43h in Blogs by

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

12 Aug

Posted at 10:02h in Blogs by

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)

03 Jun

Posted at 12:09h in Blogs by

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

02 May

Posted at 06:41h in Blogs by

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

28 Nov

Posted at 00:00h in Blogs by

In POSEIDON study, a treatment-naive patients with metastatic non-small cell lung cancer (NSCLC), tremelimumab (anti-CTLA-4 antibody) plus durvalumab (anti-PD-L1 antibody) and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in median Overall Survival (OS) [14 months vs 11.7 months] and median Progression Free Survival (PFS) [6.2 months vs 4.8 months] compared to platinum-based chemotherapy. The addition of tremelimumab to durvalumab and chemotherapy led to more durable responses hence FDA approved this combination for metastatic NSCLC in a front-line setting. (Ref: Johnson ML et al. Clin Oncol. Nov 3, 2022 and  U.S.FDA. Gov. Nov 10, 2022)

#oncologyresearch #clinicalresearch #clinicaldevelopment

29 Oct

Posted at 10:55h in Blogs by

In this Phase III study (CHOICE-01), patients with treatment-naive, advanced NSCLC with EGFR/ALK mutations, treatment with toripalimab (a humanized IgG4K monoclonal antibody specific for human PD-1) in combination with chemotherapy showed significantly better PFS (median PFS 13.1 v 5.5 months). This study supports the use of toripalimab in combination with chemotherapy as a front-line treatment option for patients with advanced NSCLC without EGFR/ALK driver mutations. (Ref: Wang Z et al. J Clin Oncol. Oct 7, 2022)

#oncologyresearch #clinicalresearch #clinicaldevelopment

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23 Sep

Posted at 10:30h in Blogs by

In patients with advanced NSCLC without EGFR, ALK, or ROS1 genomic tumor aberrations, treatment with cemiplimab plus chemotherapy showed a consistent relationship between ORR and baseline PD-L1 expression, with benefits versus chemotherapy alone seen across all levels of baseline PD-L1 expression; there was also a clear association between a continuous measure of changes in tumor size over time and baseline PD-L1 expression. Cemiplimab is only the second anti-PD-1/PD-L1 agent to show efficacy in advanced NSCLC as both monotherapy and in combination with chemotherapy for both squamous and non-squamous histologies. (Ref: Gogishvili M et al. Nat Med. Aug 25, 2022)
#oncologyresearch #clinicalresearch #clinicaldevelopment
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