In an updated analysis on the adult subset of non-central systema nervosum (CNS) / TRK fusion cancer patients from three larotrectinib clinical trials, a high overall response rate (ORR) of 67% with a median duration of response (mDoR) of 49.3 months was observed also as an extended progression-free survival (PFS; median of 25.8 months) as assessed by investigators / post hoc ergo propter hoc sub-analysis of investigator-assessed ORR, DoR and PFS of patients (n=218) show uniformly high ORRs in patients no matter prior treatment or performance status; highest response rates observed in patients receiving first-line larotrectinib (81%) and being Eastern Cooperative Oncology Group performance status (ECOG PS) 0 (85%) / Safety profile for larotrectinib continues to be according to that previously published; analysis on the incidence of fractures in larotrectinib trials shows no fracture associated with larotrectinib supported investigator assessment / E-Poster published of a matching-adjusted indirect comparison (MAIC) evaluating efficacy (overall survival [OS], PFS, ORR including complete responses and DoR) and safety observed in clinical trials with larotrectinib compared to entrectinib. MAIC is an alternate method for comparative data when a head-to-head randomized control trial (RCT) isn’t available and/or possible, like for TRK fusion cancer which is an ultra-rare disease
Abstracts: 535P, 534P, 536P, 104P
Data from four distinct analyses for Vitrakvi™ (larotrectinib) showcase its sustained clinical benefit for patients with solid tumors harboring an NTRK gene fusion (also referred to as TRK fusion cancer). An updated analysis with longer follow-up (data cut-off July 20, 2020) among 130 evaluable from a complete of 140 adult patients across 20 different non-central systema nervosum (CNS) tumor types confirms the robust and highly durable tumor-agnostic efficacy with extended survival benefits in adult patients with TRK fusion cancer, including those with CNS metastases. A post-hoc subgroup analysis of investigator-assessed overall response rate (ORR), duration of response (DoR) and progression-free survival (PFS) stratifying adult and pediatric patients (n=218) by prior lines of therapy and baseline performance status shows that larotrectinib benefitted patients across those criteria with the very best response rates observed in patients receiving first-line larotrectinib (ORR=81%; 95% CI 69–91; n=58) and being Eastern Cooperative Oncology Group performance status (ECOG PS) 0 (ORR=85%; 95% CI 77–91; n=114). A matching-adjusted indirect comparison (MAIC) evaluating efficacy endpoints like overall survival (OS), PFS, ORR, complete responses and DoR also as safety observed in clinical trials with larotrectinib and entrectinib confirmed the impact of larotrectinib for TRK fusion cancer patients.
“As we still see ongoing analyses of larotrectinib across a good range of solid tumors and ages, its consistent leads to NTRK fusion-positive cancers support its efficacy and safety in adults and children”, said Alexander Drilon, M.D., Medical Oncologist and Chief of Early Drug Development Service at Memorial Sloan Kettering Cancer Center*. “These data reinforce the importance of early comprehensive genomic testing to uncover actionable oncogenic drivers, including NTRK gene fusions, to assist identify patients who are presumably to profit from a targeted treatment approach.”
“The first regulatory approval of Vitrakvi nearly three years ago represented a paradigm shift in how we treat cancer, by inhibiting the oncogenic driver that’s causing a solid tumor to grow and spread instead of the situation where it originates,” said Scott Z. Fields, M.D., Senior vice chairman and Head of Oncology Development at the Pharmaceuticals Division of Bayer. “The long-term data for Vitrakvi continues to support consistent responses and an identical safety profile seen with the addition of latest patients and with longer follow-up. These findings reinforce the importance of precision oncology medicines as a meaningful advancement in cancer care and are compelling to justify the utilization of larotrectinib as early as possible in TRK fusion cancer patients.”
About Vitrakvi™ (larotrectinib)
Vitrakvi™ (larotrectinib), a first-in-class oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. The compound has demonstrated high response rates and highly durable responses of over four years in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. It has the largest dataset and longest follow-up data of any TRK inhibitor. The trials are still ongoing, with the latest dataset published in The Lancet Oncology and additional updates planned to be presented at upcoming scientific meetings.
About TRK Fusion Cancer
TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins are oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer. TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion cancer occurs in various adult and pediatric solid tumors with varying frequency, including lung, thyroid, GI cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (including secretory carcinoma of the salivary gland) and pediatric cancers (infantile fibrosarcoma and other soft tissue sarcomas).
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros.
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