Larotrectinib Delivers 81% Overall Response Rate in an Expanded Dataset of 109 TRK Fusion Cancer Patients Across Ages and Tumor Types
Larotrectinib Delivers 81% Overall Response Rate in an Expanded Dataset of 109 TRK Fusion Cancer Patients Across Ages and Tumor Types -- Median duration of response (mDOR) in primary dataset not reached after follow-up of 17.6 months(1) |
[21-October-2018] |
WHIPPANY, N.J., Oct. 21, 2018 /PRNewswire/ -- Bayer and Loxo Oncology, Inc. (Nasdaq: LOXO), today announced updated clinical data for larotrectinib in adult and pediatric patients with TRK fusion cancer across 24 unique tumor types. The update included approximately one year of additional follow-up for a primary dataset of 55 patients as well as results from a supplementary dataset of 67 patients.1 The overall response rates (ORR) in these groups were 80 percent and 81 percent, respectively, while the median duration of response (mDOR) had not yet been reached in either group.1 Complete responses (CR) in the primary dataset continued to mature, increasing to 18 percent, while the additional patients in the supplementary dataset experienced a CR rate of 17 percent.1 These data are being presented today at the ESMO 2018 Congress (European Society for Medical Oncology).
This is the only analysis to examine the efficacy and safety of a single-purpose drug for the treatment of TRK fusion cancer. The 122-patient integrated dataset (109 patients included in the efficacy analysis) included both adult and pediatric patients with TRK fusion cancer across 24 unique tumor types, ranging in age from approximately one month to 80 years.1 Tumor types included 10 distinct soft tissue sarcomas, salivary gland, infantile fibrosarcoma, thyroid, lung, melanoma, colon, gastrointestinal stromal tumor, breast, bone sarcoma, cholangiocarcinoma, carcinoma of unknown primary, congenital mesoblastic nephroma, appendiceal, and pancreas cancers.1 Safety results were generally consistent with previous presentations, with the majority of adverse events (AE) grade 1 or 2.1 No treatment-related grade 3 or 4 AEs occurred in more than 5 percent of patients.1 "It is exciting to see larotrectinib deliver responses to patients in these studies with TRK fusion cancer, across different ages, tumor sites of origin, or CNS involvement," said Ulrik Lassen, M.D., Ph.D., Department of Oncology, Rigshospitalet, Copenhagen. "In the supplementary set, the response rate is nearly the same as in the primary set and duration of response has actually increased with longer patient follow-up. The larotrectinib experience provides strong clinical evidence supporting the development of single-purpose drugs against oncogenic driver targets, and underscores the importance of tumor genomic profiling capable of identifying NTRK gene fusions alongside other activating alterations." "These data from a large patient group with TRK fusion cancer are truly encouraging – bringing us one step further to delivering this treatment to patients," said Dr. Scott Z. Fields, Senior Vice President and Head of Oncology Development at Bayer's Pharmaceutical Division. "We look forward to bringing this potential treatment option to adults and children with TRK fusion cancer as soon as possible." The U.S. Food and Drug Administration (FDA) granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA). Bayer has submitted a Marketing Authorization Application (MAA) in the European Union (EU) and additional filings in other markets are underway. Detailed Results Presented at ESMO 2018 Congress The datasets included patients with RECIST-evaluable disease enrolled to the three clinical trials, regardless of prior therapy or testing methodology used to establish their TRK fusion status.1 In the ESMO 2018 Congress presentation, response evaluations were based on investigator assessment.1 In the primary dataset, the overall response rate (ORR) was 80 percent (44/55) (95% CI: 67-90%), with a 62 percent partial response (PR) rate and an 18 percent complete response (CR) rate.1 In the supplementary dataset, the ORR was 81 percent (44/54) (95% CI: 69-91%), with a 65 percent PR rate and a 17 percent CR rate.1 Across both datasets, the ORR was 81 percent (88/109) (95% CI: 72-88%), with a 63 percent PR rate and a 17 percent CR rate.1 The ORR analyses for the supplementary and integrated datasets included nine patients with unconfirmed PRs awaiting confirmatory response assessments; they did not include 13 patients who were awaiting an initial response assessment and continuing on study.1 Median duration of response (mDOR) had not been reached in either the primary dataset or supplementary dataset, with median follow-up of 17.6 months and 7.4 months, respectively.1 In the primary dataset, Kaplan-Meier landmark analyses improved since the July 2017 data cut-off date.1 At six months, 88 percent of responses were ongoing (83 percent based on the July 2017 data cut-off date). At 12 months, 75 percent of responses were ongoing (71 percent based on the July 2017 data cut-off date). Kaplan-Meier landmark analyses of the supplementary dataset were highly concordant with the primary dataset.1 At six months, 93 percent of responses were ongoing and at 12 months, 81 percent of responses were ongoing.1 Across the integrated dataset, as of the July 2018 data cut-off date, 84 percent of responding patients remained on treatment or had undergone surgery with curative intent.1 The safety data presented at the ESMO 2018 Congress encompassed the entire larotrectinib safety database in cancer patients (n=207). The majority of adverse events (AE) reported were grade 1 or 2.1 No treatment-related grade 3 or 4 AEs occurred in more than 5 percent of patients.1 Of the 122 patients with TRK fusion cancer, 11 patients (9 percent) required larotrectinib dose reductions.1 In all cases, patients whose doses were reduced maintained their best response at the lower dose.1 One patient (<1 percent) discontinued larotrectinib due to an AE.1 About Larotrectinib In November 2017, Bayer and Loxo Oncology entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a TRK inhibitor in clinical development. Bayer and Loxo Oncology will jointly develop the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Bayer and Loxo Oncology will co-promote the products. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov or visit www.loxooncologytrials.com. Larotrectinib has not been approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority. About TRK Fusion Cancer About Oncology at Bayer About Bayer © 2018 Bayer Media Contact: Forward-Looking Statement
Abstract: 409O PP-LAR-US-0477-1 10/2018 Intended for U.S. Media Only View original content to download multimedia:http://www.prnewswire.com/news-releases/larotrectinib-delivers-81-overall-response-rate-in-an-expanded-dataset-of-109-trk-fusion-cancer-patients-across-ages-and-tumor-types-300734764.html SOURCE Bayer | ||||||||||||||
Company Codes: NASDAQ-NMS:LOXO |
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