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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

BerGenBio Receives FDA Fast Track Designation For Bemcentinib In STK11-mutated Advanced/Metastatic Non-small Lung Cancer (NSCLC)

Published date:
11/09/2021
Excerpt:
BerGenBio a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for bemcentinib in combination with an anti-PD-(L)1 agent as treatment for patients with STK11 altered advanced/metastatic NSCLC patients without actionable mutations.
Secondary therapy:
AB-101
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study to Investigate the Safety, Tolerability, and Preliminary Anti-tumor Activity of Bemcentinib in Combination With Pembrolizumab Plus Pemetrexed and Carboplatin in Adult Participants With Untreated Non-squamous Non-small Cell Lung Cancer

Excerpt:
...- Histologically-confirmed or cytologically confirmed diagnosis of stage of advanced (Stage IIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11 mutation,...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A clinical study to assess the safety, tolerability, and anti-tumour activity of the investigational drug (bemcentinib) in combination with the standard of care (a chemotherapy drug combination consisting of pembrolizumab plus pemetrexed and carboplatin) in adult patients with a type of advanced or metastatic lung cancer called non-squamous non-small cell lung cancer.

Excerpt:
...Have a histologically- or cytologically confirmed diagnosis of advanced (StageIIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11mutation, not amenable to curative therapy, irrespective of PD-L1 status and withoutactionable mutations (Phase 2a).5. ...