Plain Language Summary
What is this summary about?
This is a summary of a publication that reported data from participants in two clinical trials that studied a targeted cancer medicine called larotrectinib in a total of 20 participants with TRK fusion-positive lung cancer that had spread outside of the lungs. ‘TRK fusion-positive’ means that a patient’s lung cancer had a specific change in the gene called NTRK. The researchers wanted to know whether larotrectinib could shrink the participants’ tumors and what side effects it caused.
What were the main results reported by the researchers?
Researchers found that among the participants who took 100 milligrams (mg) of larotrectinib twice a day, 73% had their tumors respond to treatment, which means that their tumors shrank by over 30% or disappeared completely.
81% of the participants whose tumors responded to treatment continued to respond for 1 year. After 2 years, 65% continued to respond. The median time that participants’ tumors continued to respond to treatment was 33.9 months. The median is the middle number in a set of numbers when ordered from lowest to highest. In this case, the ‘median’ means that half of the participants continued to respond to treatment for more than 33.9 months.
The median time that participants lived without their tumors growing was 35.4 months. This means that half of the participants lived without their tumors growing for more than 35.4 months.
The median time that participants lived during the trials after starting treatment was 40.7 months.
80% of participants (16 out of 20) developed side effects. Most of these side effects were manageable. In this summary, side effects are the medical problems that happened during both trials that the researchers thought were possibly related to larotrectinib. The most common side effect was muscle aches.
10% of participants (2 out of 20) had severe side effects. The severe side effects were an overreaction by the immune system in response to treatment like an allergic reaction, an increase in body weight, and muscle aches. Severe side effects may cause medical problems that are significant enough to require medical attention or hospital care and may require a change in treatment dose.
This is an abstract of the Plain Language Summary of Publication article.
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Acknowledgments
Bayer Healthcare would like to thank the clinical trial participants and their family members and caregivers, as well as the staff members at the trial centers who cared for the participants in the clinical trials. They would also like to thank the patient authors and additional patient reviewers who contributed to this summary.
Disclosure statement
Alexander Drilon, MD reports honoraria from 14ner/Elevation Oncology, Amgen, Abbvie, AnHeart Therapeutics, ArcherDX, AstraZeneca, Beigene, BergenBio, Blueprint Medicines, Bristol Myers Squibb, Boehringer Ingelheim, Chugai Pharmaceutical, EcoR1, EMD Serono, Entos, Exelixis, Helsinn, Hengrui Therapeutics, Ignyta/Genentech/ Roche, Janssen, Loxo/Bayer/Lilly, Merus, Monopteros, MonteRosa, Novartis, Nuvalent, Pfizer, Prelude, Regeneron, Repare RX, Springer Healthcare, Takeda/Ariad/ Millenium, Treeline Bio, TP Therapeutics, Tyra Biosciences, Verastem, Zymework; served on advisory boards for Bayer, MonteRosa, Abbvie, EcoR1 Capital, LLC, Amgen, Helsinn, Novartis, Loxo/Lilly, AnHeart Therapeutics; consulted for MonteRosa, Innocare, Boundless Bio, Treeline Bio, Nuvalent, 14ner/Elevation Oncology, Entos, Prelude, Bayer, Applied Pharmaceutical Science, Bristol Myers Squibb, Enlaza, Pfizer, Roche/Genetech, Nuvalent, Two River, Lilly/Loxo; research funding (paid to institution) from Foundation Medicine, GlaxoSmithKlein, Teva, Taiho, PharmaMar; equity in mBrace, Treeline; copyright Copyright: Selpercatinib-Osimertinib (US 18/041,617, pending; royalties from Wolters Kluwer, UpToDate; food/beverage from Merck, Puma, Merus, Boehringer Ingelheim; and CME honoraria from Answers in CME, Applied Pharmaceutical Science, Inc, AXIS, Clinical Care Options, Doc Congress, EPG Health, Harborside Nexus, I3 Health, Imedex, Liberum, Medendi, Medscape, Med Learning, MedTalks, MJH Life Sciences, MORE Health, Ology, OncLive, Paradigm, Peerview Institute, PeerVoice, Physicians Education, Projects in Knowledge, Resources, Remedica Ltd, Research to Practice, RV More, Targeted Oncology, TouchIME, WebMD. Jessica J. Lin, MD has served as a paid consultant for Genentech, C4 Therapeutics, Blueprint Medicines, Nuvalent, Bayer, Elevation Oncology, Novartis, Mirati Therapeutics, AnHeart Therapeutics, CLaiM Therapeutics, Ellipses, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Yuhan, Merus, Regeneron, Pfizer, and Turning Point Therapeutics; received institutional research funds from Hengrui Therapeutics, Turning Point Therapeutics, Neon Therapeutics, Relay Therapeutics, Bayer, Elevation Oncology, Roche, Linnaeus Therapeutics, Nuvalent, and Novartis; has received travel support from Pfizer and Merus. Domnita-Ileana Burcoveanu reports being an employee of Bayer. Christopher Ollis reports paid consulting for Bayer. Victor Moreno, MD, PhD reports paid consulting for Abbvie, Roche, Bayer, Bristol Myers Squibb, Janssen, Syneos, Affimed, AstraZeneca, Merck and Ellipses Pharma. and institutional funding from Abbvie, Achilles, Adaptimmune, Adc Therapeutics, Ascendis Pharma, Astrazeneca, Bayer, Beigene, Bicycle Tx, Bioinvent, Biomea Fusion, Biontech, Bms, Boehringer, C4 Therapeutics, Calico Life Sciences Llc, Celgene, Constellation, Crescendo Biologics, Cullinan, Daiichi Sankyo, Debiopharm, Dragonfly, Enliven Therapeutics, Epizyme, Exelixis, Famewave, F-Star Beta Limited, Genentech, Genmab, Gilead, Grey Wolf Therapeutics, Gsk, Hexal Ag & Sandoz, Hifibio, Hookipa Biotech, Hutchmed, Igm Biosciences, Imcheck Therapeutics, Immunocore, Immutep, Incyte Iomx Therapeutics, Iovance, Italfarmaco, Iteos, Janssen, Light Chain Bioscience, Lilly, Loxo Oncology, Merck, Merus, Miltenyi Biomedicine, Monta Biosciences, Msd, Mythic Therapeutics, Ningbo Newbay, Novartis, Oxford Biotherapeutics, Pfizer, Pharmamar, Pmv Pharma, Prelude Therapeutics Inc, Pyxis Oncology, Regeneron, Relay Terapeutics, Repare Therapeutics, Revolution, Roche, Schrödinger, Scorpion Therapeutics, Seagen, Shattucks, Synthorx, Takeda, Tango Therapeutics, Tesaro, Totus Medicines, Turning Point Therapeutics, Vividion Therapeutics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing and editorial assistance in the development of this summary were funded by Bayer Healthcare and provided by Zack Fey and Matt Chapman of the Center for Information & Study on Clinical Research Participation (CISCRP), a non-profit organization focused on educating and informing the public about clinical research participation.
Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Funding
This summary was funded by Bayer Healthcare. Bayer Healthcare reviewed and approved this summary.