Bayer's Pan-Cancer Drug Vitrakvi Demonstrates Strong Efficacy in TRK Fusion Cancer Patients with Brain Metastases and Primary CNS Tumors
Jun 06, 2019 10:23
CST Updated
10:23
Bayer
Pharmaceutical Product R&D Developer
June 06, 2019 /Bio ValleyBIOON/ -- German pharmaceutical giantBayer(Bayer) recently announced data from patients with TRK fusion cancers and brain metastases or primary central nervous system (CNS) tumors at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago.Clinical TrialsThe first prospective analysis confirmed the robust efficacy of the “broad-spectrum” targeted anticancer drug Vitrakvi (larotrectinib) in adult and pediatric patients. In TRK fusion cancer patients with intracranial disease, Vitrakvi demonstrated efficacy across age groups andTumorHistological remission and durable disease control were both achieved.
This analysis identified 24 patients with intracranial disease from three clinical studies (adult Phase I study NCT02122913, 1 patient; pediatric Phase I study NCT02637687, 12 patients; adult/adolescent Phase II basket study NCT02576431, 11 patients). Eighteen cases were primary CNSTumor(Data cutoff: February 19, 2019), with 14 cases evaluable. Among 6 patients with brain metastases, 5 were evaluable (data cutoff: July 30, 2018).
Among the 5 evaluable patients with TRK fusion-positive cancers and brain metastases, the overall response rate (ORR) was 60% (n=3; all partial responses [PR]) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), while the remaining 40% of patients (n=2) achieved stable disease (SD). Four patients were still receiving treatment at the data cutoff, with a duration of treatment up to 18.4 months.
14 Cases of Evaluable TRK Fusion-Positive Primary CNS TumorsTumorAmong patients with glioma, including glioblastoma, oligodendroglioma, and astrocytoma, the overall response rate (ORR) was 36% (n=5; 95% CI: 13–65), with 2 cases of complete response (CR) and 3 cases of partial response (PR). All other patients (64%, n=9) achieved stable disease. The disease control rate (DCR: defined as CR + PR + stable disease [SD] lasting ≥24 weeks) was 71%.
Dr. Alexander Drilon, Chief Investigator and Research Director of Early Drug Development Services at Memorial Sloan Kettering Cancer Center, stated, “Overall, these data further confirm the activity of larotrectinib in TRK fusion cancers, regardless of tumor type and age, including those with brain metastases or primary CNSTumorTRK fusion cancer patients. In these analyses, the rapid and durable responses to larotrectinib in patients were encouraging.”
Senior Vice President of Bayer's Pharmaceutical Division andTumorScott Z. Fields, Ph.D., Head of Development, stated, “These data are important as we continue to see the efficacy of larotrectinib in treating TRK fusion cancers across different types and ages.”
NTRK gene fusions are aberrant genetic alterations present in a wide range of tumor types, leading to dysregulated tropomyosin receptor kinase (TRK) signaling andTumorGrowth. Increasing evidence indicates that the NTRK genes, which encode TRK proteins, may fuse abnormally with other genes, generating signals that can drive cancer growth in multiple sites throughout the body.
The active pharmaceutical ingredient of Vitrakvi is larotrectinib, a potent, oral, selective tropomyosin receptor kinase (TRK) inhibitor designed to directly target TRKs (including TRKA, TRKB, and TRKC), thereby shutting down the signaling pathways that drive tumor growth in TRK fusion cancers. In clinical studies, Vitrakvi has demonstrated significant and durable antitumor activity in TRK fusion cancers, regardless of patient age andTumorType.
In late November 2018, Vitrakvi was approved by the U.S.FDAApproved for pediatric and adult patients with advanced solid tumors harboring NTRK gene fusions, specifically: those without known acquired resistance mutations, with metastatic disease or where surgical resection may lead to severe complications, and who have no satisfactory alternative treatment options or have experienced disease progression during treatment.
This approval makes Vitrakvi the first-ever oral TRK inhibitor, as well as the first “broad-spectrum” anticancer drug that is tumor-agnostic, ushering in the era of “TumorThe New Era of "Tumor-Agnostic" Therapy. (Bioon.com)