Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023
FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02716116 (A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788), which is not on this map. Cited by 29 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer
Who cites it
29 citing papers in PubMed, 36 citations in OpenAlex.
- First-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients WithJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Trial
- CRISPR-Scan: Cas13a Mismatch Tolerance Enabled Ultra-Multiplexed Detection of Same-Site Indels in Acute Myeloid Leukemia.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Salidroside Alleviates Mobocertinib-Induced Cardiotoxicity by Improving Cardiac Electrophysiology.Cardiovascular toxicology · 2026Article
- Mutant-Selective Binding ofInternational journal of molecular sciences · 2026Article
- FDA-Approved Drugs Containing Amide Functionality in the Last Five Years (2021-2025): Pharmaceutical Use, Trends and Synthetic Approaches.Medicines (Basel, Switzerland) · 2026Review
- Resistance to EGFR Inhibitors in NSCLC: Mechanistic Insights and Emerging Therapies.International journal of molecular sciences · 2026Review
- Efficacy and safety outcomes of emerging EGFR‑TKIs for patients with non‑small cell lung cancer with EGFR exon 20 insertion mutations: A systematic review and meta‑analysis.Oncology letters · 2025Article
- Research advancements of antibody drug conjugates in non-small cell lung cancer with HER2 alterations.Journal of translational medicine · 2025Review
- Real-World Performance of the EasyPGXBiomedicines · 2025Article
- New advances in the treatment of EGFR exon20ins mutant advanced NSCLC.American journal of cancer research · 2025Review
- Evolving treatment strategies for EGFRex20ins-mutated NSCLC: a comprehensive review of Amivantamab's role and future directions.Ecancermedicalscience · 2025Review
- Review
- Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Cancer: Current Use and Future Prospects.International journal of molecular sciences · 2024Review
- Drug development and evidence for lung cancer targeted therapy in Eastern Asia.The Lancet regional health. Western Pacific · 2024Review
- A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [Investigational new drugs · 2024Article
- CoHIT: a one-pot ultrasensitive ERA-CRISPR system for detecting multiple same-site indels.Nature communications · 2024Article
- Multinational proficiency tests for EGFR exon 20 insertions reveal that the assay design matters.Scientific reports · 2024Article
- Developments in predictive biomarker testing and targeted therapy in advanced stage non-small cell lung cancer and their application across European countries.The Lancet regional health. Europe · 2024Review
- Next-Generation Sequencing in Lung Cancers-A Single-Center Experience in Taiwan.Medicina (Kaunas, Lithuania) · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors at 3 institutions in 1 country.
Funding
Abstract
On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The approval was based on data from Study AP32788-15-101 (NCT02716116), an international, non-randomized, multi-cohort clinical trial that included patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The overall response rate in 114 patients whose disease had progressed on or after platinum-based chemotherapy was 28% [95% confidence interval (CI), 20%-37%] with a median duration of response of 17.5 months (95% CI, 7.4-20.3). The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. Product labeling includes a Boxed Warning for QTc prolongation and torsades de pointes. This is the first approval of an oral targeted therapy for patients with advanced EGFR exon 20 insertion mutation-positive NSCLC.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.