Over the past couple of decades, biomarker driven enrichmentclinical trials have proven to be an important tool in clinical drugdevelopment, especially for targeted anti-cancer drugs. For larotrectinib efficacy was demonstrated across 12 different conventional cancer indications and for pembrolizumab the number was 15.
Due to the low prevalence of the different molecular aberrations, data from several small “basket” trials was pooled in order to document the efficacy of the two drugs. With the approval of larotrectinib and the MSI-H/dMMR indication for pembrolizumab, the translational research methodology has demonstrated its potential in relation to drug development and made the way for a more precise and individualized anti-cancer therapy.
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Research is underway to identify treatment approaches thatmay address some of the challenges to existing treatment, Key players, such asBayer, Turning Point Pharmaceuticals, Daiichi Sankyo among others.
Initially identified in colorectal and papillary thyroid carcinomas,NTRK fusions have since been found in ultiple tumour types from both adult andpaediatric patients. These cancers can be grouped into two general categories according to the frequency at which these fusions are detected.
Rare cancer types highly enriched for NTRK fusions. For example, the ETV6–NTRK3 fusion is considered practically pathognomonic in secretory breast carcinoma, MASC, congenital mesoblastic nephroma (cellular or mixed subtypes), and infantile fibrosarcomas, with a prevalence of >90% in select series of patients.
Other cancer types in which NTRK fusions are found at muchlower frequencies (5–25% or <5%), including rare subsets of some commontumours (such as breast, lung, and colorectal cancers, and melanoma). Papillary thyroid cancers, Spitzoid neoplasms, gastrointestinal stromal tumours (GIST) lacking canonical KIT, PDGFRA, or RAS alterations, and certain paediatric gliomas are among the tumours types that have been shown to harbour NTRK fusions with frequencies of 5–25%. NTRK fusions can be detected in <5% (predominantly <1%) of lung or pancreatic adenocarcinomas, head and neck squamous cell, bile duct, breast etc.
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