- Source : Press Release
- Date : 2021-07-14
- Event type : Marketed
- Companies : Bayer AG
'Bayer's Cancer Treatment Vitrakvi Presents a New Paradigm'
Bayer's Vitrakvi (ingredient name: larotrectinib) is leading a paradigm shift in cancer treatment designs tailored to treat tumors based on biomarkers rather than specific carcinomas, the company said Tuesday.
Patients with NTRK (neurotrophic receptor tyrosine kinase) gene fusion can use Vitrakvi from 1 month of age to adults regardless of carcinoma after genetic testing.
NTRK gene fusion benign tumors occur when the NTRK gene fuses with another unrelated gene to produce a mutated TRK protein. The TRK (tropomyosin receptor kinase) fusion protein acts as an oncogenic factor that promotes the growth and proliferation of cancer cells. However, as the protein does not associate itself with any specific cells, it can induce tumors at any site with TRK receptors.
The company obtained approval for Vitrakvi after submitting the data for a total of 55 patients with NTRK gene fusion confirmed from three clinical studies. It then conducted an additional clinical study with 159 patients in an expanded population to evaluate long-term efficacy and safety analyses.
According to the efficacy evaluation of a total of 159 TRK gene fusion-positive cancer patients who received Vitrakvi treatment, the objective response rate (ORR) was 79 percent, the complete response rate (CR) was 16 percent, and the partial response rate (PR) was 63 percent.
Vitrakvi is a treatment for use in adult and pediatric patients with NTRK gene fusions without a known acquired resistance mutation, with a high likelihood of locally advanced, metastatic, or severe morbidity following surgical resection, and for solid cancer patients who have relapsed after conventional treatment or for which no treatment is currently available.
"Vitrakvi has shown to be effective in a variety of carcinomas," Professor Oh Do-youn of the Department of Oncology at Seoul National University Hospital said in a news conference. "Due to the dramatic reaction, some patients can expect a complete cure and improve their quality of life."
This means that patients with NTRK gene fusions now have an alternative treatment strategy in addition to the previous standard of care, she added.
Professor Oh stressed that conducting next-generation sequencing tests that include NTRK fusion has become important more than ever as there are new options to try after treatment failure, not only for patients with rare cancer for whom treatment options were not available but also for those who have failed to confirm efficacy from conventional targeted therapies.
"However, studies are still insufficient on the combination therapy with existing treatments or the treatment sequence," Oh said. "Despite the lack of studies, Vitrakvi's effect is very good in actual treatment experience, adverse reactions are few, and patients can maintain for a long time. Therefore, I believe it will be better to use it sooner than chemotherapy, which has many side effects and a short duration of treatment."
Bayer stressed that it is working hard to obtain reimbursement for the drug, which passed the Cancer Disease Review Committee, the first step to gain reimbursement for treatment, in late May.
"We are working closely with the health authorities to address the unmet therapeutic needs of patients with NTRK fusion oncology and improve patient access," said Bae Joo-hee, Bayer's medical affairs oncology advisor and manager. "We are doing our best to receive reimbursement for the drug."