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Association details:

Evidence:

Evidence Level:
Sensitive: B - Late Trials
New
Title:
Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer
Published date:
04/28/2021
Excerpt:
Takeda Pharmaceutical Company Limited...today announced that that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy.
Evidence Level:
Sensitive: B - Late Trials
Title:
Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations
Published date:
04/27/2020
Excerpt:
Takeda Pharmaceutical Company Limited...today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
Excerpt:
...- Histologically or cytologically confirmed nonsquamous cell locally advanced recurrent, or metastatic (Stage IV) non-small cell lung cancer (NSCLC) - Documented epithelial growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (United States [US] sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations except EGFR mutations for which there are approved anti-EGFR TKIs (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid) - Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation - At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 - Life expectancy ≥3 months - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 ...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:
A Trial of TAK-788 (AP32788) in Non-small Cell Lung Cancer (NSCLC)
Excerpt:
...Participants with an - EGFR exon 20 insertion, with or without prior anticancer treatments. ...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788
Excerpt:
...A documented epidermal growth factor receptor (EGFR) mutation with in-frame exon 20 insertion, confirmed as follows:...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
A Study of TAK-788 in Japanese Adults With Non-Small Cell Lung Cancer
Excerpt:
...A documented EGFR in-frame exon 20 insertion (including A763_Y764insFQEA, V769_D770insASV, D770_N771insNPG, D770_N771insSVD, H773_V774insNPH, or any other in-frame exon 20 insertion mutation) by a local test that has been analytically validated per local authority guidelines....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
An Expanded Access Protocol for Mobocertinib in Refractory Non-small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Exon20 Insertion Mutations
Excerpt:
...Have a documented EGFR in-frame exon 20 insertion mutations 3....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Takeda Presents Positive Results for Mobocertinib in Patients with EGFR Exon20 Insertion+ mNSCLC who Received Prior Platinum-Based Chemotherapy
Published date:
01/28/2021
Excerpt:
Takeda Pharmaceutical Company Limited...today announced new data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in previously treated patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC)...clinically meaningful responses, with a confirmed objective response rate of 35% as assessed by investigator and 28% as assessed by an independent review committee (IRC)...Responses shown with mobocertinib were durable, with a median duration of response of 17.5 months as assessed by IRC
Evidence Level:
Sensitive: C3 – Early Trials
Title:
OA04.03 - Mobocertinib in NSCLC With EGFR Exon 20 Insertions: Results From EXCLAIM and Pooled Platinum-Pretreated Patient Populations
Published date:
01/12/2021
Excerpt:
Mobocertinib demonstrated clinically meaningful benefit in previously treated patients with NSCLC and EGFRex20ins mutations, with a manageable safety profile.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
1261MO - Updated results from a phase I/II study of mobocertinib (TAK-788) in NSCLC with EGFR exon 20 insertions (exon20ins)
Published date:
09/18/2020
Excerpt:
Mobocertinib demonstrated antitumor activity in pts with advanced NSCLC with EGFR exon20ins. The safety profile for mobocertinib was consistent with other EGFR TKIs.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
Indirect comparison of TAK-788 vs real-world data outcomes in refractory non-small cell lung cancer (NSCLC) with EGFR exon 20 insertions.
Published date:
05/13/2020
Excerpt:
A total of 99 pts were included, n=28 TAK-788 and n=71 RWD; mean age 62/65 y; male 25%/46%...Specifically, after weighting, median PFS for TAK-788 vs RWD is 7.3 vs 3.5 mo, and ORR is 43% vs 13%...Despite a more heavily pretreated pt population, the efficacy of TAK-788 in pts with refractory NSCLC with EGFR exon 20 insertions appears better than other second-line treatment options used in the real-world setting.
DOI:
10.1200/JCO.2020.38.15_suppl.9580
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
First report of safety, PK, and preliminary antitumor activity of the oral EGFR/HER2 exon 20 inhibitor TAK-788 (AP32788) in non–small cell lung cancer (NSCLC).
Published date:
05/16/2018
Excerpt:
Of 14 evaluable pts, 3 had PR (80 mg, n = 2, both confirmed; 120 mg, single PR awaiting confirmation), 6 had SD (40 mg, n = 3; 80 mg, n = 2; 120 mg, n = 1), and 5 had PD as best response (40 mg, n = 3; 80 mg, n = 1; 120 mg, n = 1); all pts with PR or SD had EGFR exon 20 insertions...TAK-788 exhibits antitumor activity in pts with EGFR exon 20 insertions with an AE profile consistent with other EGFR TKIs.
DOI:
10.1200/JCO.2018.36.15_suppl.9015
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
First report of safety, PK, and preliminary antitumor activity of the oral EGFR/HER2 exon 20 inhibitor TAK-788 (AP32788) in non–small cell lung cancer (NSCLC).
Excerpt:
...and 5 had PD as best response (40 mg, n = 3; 80 mg, n = 1; 120 mg, n = 1); all pts with PR or SD had EGFR exon 20 insertions....TAK-788 exhibits antitumor activity in pts with EGFR exon 20 insertions with an AE profile consistent with other EGFR TKIs.
DOI:
10.1200/JCO.2018.36.15_suppl.9015
Trial ID:
Evidence Level:
Sensitive: D – Preclinical
Title:
Mobocertinib (TAK-788): A Targeted Inhibitor of EGFR Exon 20 Insertion Mutants in Non-Small Cell Lung Cancer
Published date:
02/25/2021
Excerpt:
The in vitro and in vivo activity of mobocertinib was evaluated in engineered and patient-derived models harboring diverse EGFRex20ins mutations. Mobocertinib inhibited viability of various EGFRex20ins-driven cell lines more potently than approved EGFR TKIs and demonstrated in vivo antitumor efficacy in patient-derived xenografts and murine orthotopic models.
DOI:
10.1158/2159-8290.CD-20-1683
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