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DRUG:

Semena (befotertinib)

i
Other names: D-0316, D 0316, BPI-D0316
Company:
Betta Pharma, InventisBio
Drug class:
EGFR inhibitor, Tyrosine kinase inhibitor
Related drugs:
2ms
New P2 trial
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Loqtorzi (toripalimab-tpzi) • Ensacove (ensartinib) • Qi Xinke (iruplinalkib) • Semena (befotertinib) • bozitinib (APL-101) • Ariely (adebrelimab) • SHR-A1921
3ms
Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer (clinicaltrials.gov)
P2, N=30, Active, not recruiting, Betta Pharmaceuticals Co., Ltd. | Trial primary completion date: Dec 2023 --> Dec 2024 | Recruiting --> Active, not recruiting
Enrollment closed • Trial primary completion date • Metastases
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Conmana (icotinib) • Semena (befotertinib)
3ms
D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC (clinicaltrials.gov)
P2/3, N=362, Active, not recruiting, Betta Pharmaceuticals Co., Ltd. | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date • Metastases
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Conmana (icotinib) • Semena (befotertinib)
3ms
Journal
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EGFR (Epidermal growth factor receptor)
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Conmana (icotinib) • Semena (befotertinib)
3ms
New P4 trial • Minimal residual disease
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EGFR (Epidermal growth factor receptor)
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Semena (befotertinib)
3ms
Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial. (PubMed, Lung Cancer)
Befotertinib demonstrated a more profound OS benefit compared to other 3rd-generation EGFR TKI, despite that cross trial data comparison should be interpreted with caution. The safety profile was manageable and consistent with previously report data in pretreated patients with confirmed T790M mutation-positive NSCLC.
P2 data • Journal • Metastases
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EGFR (Epidermal growth factor receptor)
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Semena (befotertinib)
4ms
Potential Utility of a 4th-Generation EGFR-TKI and Exploration of Resistance Mechanisms-An In Vitro Study. (PubMed, Biomedicines)
Ba/F3 cells with an osimertinib-resistant secondary mutation were refractory to all 3G TKIs tested (alflutinib, lazertinib, rezivertinib, almonertinib, and befotertinib)...HCC827BIR cells had MET gene amplification and were sensitive to a combination of capmatinib (MET-TKI) and BI4020...This study suggests that erlotinib may be more suitable than 4G TKIs to overcome secondary mutations after front-line osimertinib. We found that off-target mechanisms that cause resistance to earlier-generation TKIs will also cause resistance to 4G TKIs.
Preclinical • Journal
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MET (MET proto-oncogene, receptor tyrosine kinase)
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Tagrisso (osimertinib) • erlotinib • Ameile (aumolertinib) • Tabrecta (capmatinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • BI-4020 • Semena (befotertinib) • Rui Bi Da (rezivertinib)
4ms
New P2 trial • Metastases
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Conmana (icotinib) • Semena (befotertinib)
4ms
A prospective, single-arm clinical study of perioperative befotertinib in patients with stage Ⅱ-ⅢB (N2) EGFR mutation-positive non-small cell lung cancer (ChiCTR2400084057)
P2, N=40, Recruiting, Department of Thoracic Surgery, Beijing Friendship Hospital, Capital Medical University; Beijing Friendship Hospital, Capital Medical University
New P2 trial
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EGFR (Epidermal growth factor receptor)
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Semena (befotertinib)
1year
China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023) (PubMed, Zhonghua Yi Xue Za Zhi)
As of August 23, 2023, the first generation EGFR-TKIs, gefitinib, icotinib, and erlotinib; the second generation EGFR-TKIs, afatinib and dacomitinib; and the third generation EGFR-TKIs, osimertinib, almonertinib, furmonertinib and befotertinib were all approved for marketing by China National Medical Products Administration (NMPA). In addition, multiple domestic third-generation EGFR-TKIs are undergoing clinical trials, such as rezivertinib (BPI-7711), limertinib (ASK120067), and oritinib (SH-1028). Meanwhile, mobocertinib and sunvozertinib, which targets EGFR 20ins mutations, were also approved by NMPA. With the increasing variety of EGFR-TKIs approved for marketing subsequently, it brings confusion to clinicians when choosing specific medications, and there is an urgent need to develop relevant treatment guidelines. Hence, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for Clinical Oncologists convened experts to integrate the research results of various EGFR-TKIs, and proposed the "China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)", to provide reference for better clinical practice.
Clinical guideline • Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Tagrisso (osimertinib) • erlotinib • Gilotrif (afatinib) • gefitinib • Conmana (icotinib) • Ameile (aumolertinib) • Vizimpro (dacomitinib) • Ivesa (firmonertinib) • Exkivity (mobocertinib) • Semena (befotertinib) • sunvozertinib (DZD9008) • Rui Bi Da (rezivertinib) • Sanrisso (rilertinib) • limertinib (ASK120067)
1year
Final overall survival (OS) results of befotertinib in patients with pretreated EGFR T790M-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) (ESMO Asia 2023)
Conclusions Befotertinib exhibited notable efficacy in both dose cohorts, showing a comparable OS benefit with other 3rd-generation EGFR TKIs in cohort A (50 mg), while even greater OS benefits in cohort B. Further, safety remained manageable and consistent with prior assessments. Overall, befotertinib maintained its remarkable efficacy with a manageable safety profile in pretreated pts with confirmed T790M mutation-positive NSCLC.
Clinical • Late-breaking abstract • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR T790M • EGFR positive
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Semena (befotertinib)
1year
New P1 trial • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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MCLA-129 • Semena (befotertinib)
over1year
Journal • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Semena (befotertinib)
over1year
Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study. (PubMed, Lancet Respir Med)
Befotertinib demonstrated superior efficacy compared with icotinib in first-line treatment for patients with EGFR mutation-positive NSCLC. Although serious adverse events were more common in the befotertinib than the icotinib arm, the safety profile of befotertinib was manageable overall.
P3 data • Journal • Metastases
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR exon 19 deletion
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Conmana (icotinib) • Semena (befotertinib)
2years
Journal
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EGFR (Epidermal growth factor receptor)
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Ameile (aumolertinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • Semena (befotertinib) • Rui Bi Da (rezivertinib) • Sanrisso (rilertinib) • limertinib (ASK120067)
over2years
D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=286, Active, not recruiting, InventisBio Co., Ltd | Trial primary completion date: Nov 2020 --> Aug 2021
Trial primary completion date
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EGFR (Epidermal growth factor receptor)
|
EGFR T790M
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Semena (befotertinib)
over2years
A Phase 2 Study of Befotertinib in Patients with EGFR T790M Mutated NSCLC after Prior EGFR TKIs (IASLC-WCLC 2022)
Befotertinib has shown favorable efficacy and manageable safety in pts with locally advanced or metastatic NSCLC harboring T790M mutation as a second-line option in the Chinese population.
Clinical • P2 data
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR T790M
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Semena (befotertinib)
over2years
D-0316 First Time in Patients Ascending Dose Study (clinicaltrials.gov)
P1, N=50, Active, not recruiting, InventisBio Co., Ltd | Trial completion date: Aug 2021 --> Dec 2022
Trial completion date
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR T790M
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Semena (befotertinib)
over2years
Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer. (PubMed, Oncologist)
D-0316 is safe, tolerable, and effective for patients with locally advanced/metastatic NSCLC with the EGFR T790M mutation who previously received EGFR-TKI.
P1 data • Clinical Trial,Phase I • Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR T790M
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Semena (befotertinib)
3years
Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer (clinicaltrials.gov)
P2, N=30, Recruiting, Betta Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
Clinical • Enrollment open
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Conmana (icotinib) • Semena (befotertinib)
3years
Clinical • New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Conmana (icotinib) • Semena (befotertinib)
over3years
Clinical • P3 data
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Conmana (icotinib) • Semena (befotertinib)
over3years
D-0316 First Time in Patients Ascending Dose Study (clinicaltrials.gov)
P1, N=50, Active, not recruiting, InventisBio Inc. | Trial primary completion date: May 2021 --> Aug 2020
Clinical • Trial primary completion date
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M
|
Semena (befotertinib)
over3years
D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=286, Active, not recruiting, InventisBio Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Nov 2020
Clinical • Enrollment closed • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR T790M
|
Semena (befotertinib)
over3years
D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC (clinicaltrials.gov)
P2/3, N=362, Active, not recruiting, Betta Pharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Feb 2021 --> Dec 2021
Clinical • Enrollment closed • Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Conmana (icotinib) • Semena (befotertinib)
almost4years
D-0316 First Time in Patients Ascending Dose Study (clinicaltrials.gov)
P1, N=50, Active, not recruiting, InventisBio Inc. | Trial completion date: Mar 2021 --> Aug 2021 | Trial primary completion date: Dec 2020 --> May 2021
Clinical • Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR T790M
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Semena (befotertinib)
almost4years
Beyond osimertinib: The development of 3-generation EGFR Tyrosine Kinase Inhibitors. (PubMed, J Thorac Oncol)
In this review, we profiled many of the third-generation EGFR TKIs in late stage clinical development (e.g. almonertinib, lazertinib, alflutinib, rezivertinib, ASK120069, SH-1028, D-0316 and abivertinib) of their interim results of phase 1-3 trials and their chemical structures when publicly available. Additionally, we summarized the results of clinical trials that previously reported third-generation EGFR TKIs (rociletinib, olmutinib, nazartinib, maverlertinib) including phase 3 results of rociletinib and naquotinib. We further profiled the next-generation combination clinical trial design of third-generation EGFR TKIs including FLAURA2 (NCT04035486), MARIPOSA (NCT04487080), ACROSS1 (NCT04500704) and ACROSS2 (NCT04500717).
Review • Journal
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EGFR (Epidermal growth factor receptor)
|
EGFR T790M
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • Xegafri (rociletinib) • nazartinib (EGF816) • Semena (befotertinib) • naquotinib (ASP8273) • Olita (olmutinib) • Rui Bi Da (rezivertinib) • Fujovee (abivertinib) • Sanrisso (rilertinib)
4years
D-0316 First Time in Patients Ascending Dose Study (clinicaltrials.gov)
P1, N=50, Active, not recruiting, InventisBio Inc. | Trial completion date: Oct 2020 --> Mar 2021 | Trial primary completion date: Aug 2020 --> Dec 2020
Clinical • Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M
|
Semena (befotertinib)
over4years
D-0316 First Time in Patients Ascending Dose Study (clinicaltrials.gov)
P1, N=50, Active, not recruiting, InventisBio Inc. | Trial completion date: Jul 2020 --> Oct 2020 | Trial primary completion date: Apr 2020 --> Aug 2020
Clinical • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M
|
Semena (befotertinib)
over4years
D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC (clinicaltrials.gov)
P2/3, N=360, Recruiting, Betta Pharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting
Clinical • Enrollment open
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion
|
Conmana (icotinib) • Semena (befotertinib)
almost5years
D-0316 First Time in Patients Ascending Dose Study (clinicaltrials.gov)
P1, N=50, Active, not recruiting, InventisBio Inc. | Recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Jul 2020 | Trial primary completion date: Dec 2019 --> Apr 2020
Clinical • Enrollment closed • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M
|
Semena (befotertinib)
almost5years
D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=286, Recruiting, InventisBio Inc. | Trial primary completion date: Dec 2019 --> Dec 2021
Clinical • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR T790M
|
Semena (befotertinib)
5years
Clinical • New P1 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M
|
Semena (befotertinib)