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Association details:
| Biomarker: | EGFR exon 20 insertion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | zipalertinib (CLN-081) (EGFR inhibitor, Tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
FDA Grants Breakthrough Therapy Designation for Cullinan Oncology’s CLN-081 in Patients with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
Published date:
01/04/2022
Excerpt:
Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan”), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for cancer patients, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for CLN-081 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) harboring epidermal growth factor (“EGFR”) exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.
Source:
Title:
Phase 1/2 Study of CLN-081 in Patients with Lung Cancer
Excerpt:
...Documented EGFR exon 20 insertion (ex20ins) mutation demonstrated by a validated test (per protocol) and performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent laboratory (all patients other than Module A Food Effect PK Assessment Module). ...
Trial ID:
Source:
Title:
Safety, Tolerability, and Antitumor Activity of Zipalertinib Among Patients With Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertions
Published date:
06/29/2023
Excerpt:
Objective responses occurred across all zipalertinib dose levels tested, with confirmed partial response (PR) observed in 28/73 (38.4%) response-evaluable patients. Confirmed PRs were seen in 16/39 (41%) response-evaluable patients at the dose of 100 mg twice a day....Zipalertinib has encouraging preliminary antitumor activity in heavily pretreated patients with EGFR ex20ins-mutant NSCLC, with an acceptable safety profile...
DOI:
10.1200/JCO.23.00152
Trial ID:
Source:
Title:
Phase (Ph) 1/2a study of CLN-081 in patients (pts) with NSCLC with EGFR exon 20 insertion mutations (Ins20).
Published date:
05/26/2022
Excerpt:
Among 70 response-evaluable pts across all dose levels, 25 (36%) had a confirmed partial response (PR), 34 (49%) had stable disease (SD), and 3 (4%) had progressive disease as a best response….In pts with heavily-pretreated advanced EGFR ins20 NSCLC, CLN-081 has a manageable safety profile, with anti-tumor activity across the range of doses tested. Further, CLN-081 has demonstrated a favorable clinical profile at the dose of 100 mg BID, with an encouraging objective response rate, response durability...
DOI:
10.1200/JCO.2022.40.16_suppl.9007
Trial ID:
Source:
Title:
Cullinan Oncology Announces Clinical and Regulatory Update for CLN-081 in NSCLC EGFR Exon 20 Patients
Published date:
03/28/2022
Excerpt:
CLN-081 is being evaluated in an ongoing Phase 1/2a clinical trial in non-small cell lung cancer (NSCLC) patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations that have progressed on or after prior therapy….Of 39 response evaluable patients, 16 achieved a confirmed partial response for a 41% confirmed response rate.
Source:
Title:
Safety and activity of CLN-081 (TAS6417) in NSCLC with EGFR Exon 20 insertion mutations (Ins20).
Published date:
05/19/2021
Excerpt:
Patients (pts) with EGFR ins20 previously treated with platinum-based therapy (tx) were eligible to enroll….Among the 25 response evaluable pts (RECIST 1.1), 10 (40 %) had a partial response (PR) (6 confirmed, 2 pending confirmation, 2 unconfirmed), 14 (56%) had stable disease (SD), and 1 (4%) had progressive disease as best response....CLN-081 has demonstrated encouraging preliminary anti-tumor activity across the full dose range tested, in multiple distinct EGFR ins20 variants, and in heavily pre-treated pts that are either naïve or refractory to other EGFR ins20 inhibitors.
DOI:
10.1200/JCO.2021.39.15_suppl.9077
Trial ID:
Source:
Title:
1345P - Preliminary safety and activity of CLN-081 in NSCLC with EGFR exon 20 insertion mutations (Ins20)
Published date:
09/14/2020
Excerpt:
We present the interim results of this multicenter, phase 1/2a trial evaluating CLN-081 in advanced, EGFR ins20-mutant NSCLC….CLN-081 demonstrates preliminary anti-tumor activity in pts refractory and naïve to other EGFR ins20 inhibitors at the lowest doses tested, with a manageable safety profile.
Trial ID:
