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• W2890762495 abstract "2507 Background: PTEFb/CDK9 mediated transcription of short-lived anti-apoptotic survival proteins and oncogenes like MYC and MCL-1 plays a critical role in a variety of cancers. We present findings from a phase I study of BAY 1251152 in pts with solid tumors and aggressive NHL. Methods: Patients with advanced or metastatic solid tumors or aggressive NHL and refractory to available therapies were eligible. BAY 1251152 was administered once weekly as a 30-minute IV infusion on Days 1, 8 and 15 of a 21-day cycle. Tumor response was assessed according to RECIST v1.1 and the revised Cheson criteria (2007). Results: A total of 31 pts were enrolled and evaluable for safety, including subjects with breast cancer (n = 6), pancreatic adenocarcionoma (5), ovarian cancer (4), and colorectal cancer (3). No DLTs were reported in the first 3 cohorts (5 mg, 10 mg and 15 mg). There was one DLT in the 22.5 mg cohort (grade 4 [G4] neutropenia), which was then expanded to 6 pts without subsequent DLTs. At 30 mg, neutropenia became the most prominent AE, with one G3 febrile neutropenia and two G4 neutropenia’s reported as DLTs in 9 evaluable pts. Three additional pts were enrolled in the 22.5 mg cohort, with one DLT (G3 neutropenia) but no other G3 or G4 drug-related AEs. The 30 mg dose was deemed the MTD. There were 4 deaths on study, none of which was attributed to study drug. Pharmacodynamic biomarker analysis showed significant dose-dependent reduction of MYC, PCNA, and MCL-1 RNA. PK was generally linear over the dose range. Antitumor activity consisted of stable disease (SD) in 9 subjects and durable SD in 3 pts: one relapsed pancreatic adenocarcinoma pt treated for 15 cycles, one double-hit DLBCL (GCB subtype, 2 prior lines) pt was treated > 22 cycles with a 40% reduction in tumor size and complete metabolic response, and a salivary gland carcinoma pt treated for > 24 cycles with a 21% reduction in tumor size; the latter 2 pts remain on treatment. Conclusions: PTEFb inhibitor BAY 1251152 had a manageable safety profile, apparent dose-proportional PK, on-target pharmacodynamic activity and signs of antitumor activity. Clinical trial information: NCT02635672." @default.
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• W2890762495 date "2018-05-20" @default.
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• W2890762495 title "Phase I dose escalation study of the first-in-class selective PTEFb inhibitor BAY 1251152 in patients with advanced cancer: Novel target validation and early evidence of clinical activity." @default.
• W2890762495 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.2507" @default.
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