Afuresertib

also known as GSK2110183 · AFU · AFURESERTIB HYDROCHLORIDE · ASB-183 · GSK-2110183B · GSK-2110183C

Developed for: cancer · B-cell chronic lymphocytic leukemia · breast cancer · castration-resistant prostate carcinoma · cervical cancer · endometrial cancer · esophageal cancer · gastroesophageal adenocarcinoma
+6 more
· hematopoietic and lymphoid system neoplasm · Langerhans cell histiocytosis · non-small cell lung carcinoma · plasma cell myeloma · refractory malignant neoplasm · triple-negative breast carcinoma
Investigated by: GlaxoSmithKline · Laekna Limited · Novartis · Novartis Pharmaceuticals · Accenture · Amgen
+1 more
· University Health Network, Toronto

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed	China (NMPA)	—	Her2-receptor negative breast cancer	2026-08-12	“the New Drug Application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE)” laekna.com ↗

Trials 19

today NCT05489744 · Ph 1 NCT05383482 · Ph 1/2 NCT04851613 · Ph 3 NCT05390710 · Ph 1 NCT04374630 · Ph 2 NCT04060394 · Ph 1/2 NCT02380313 · Ph 1 NCT02235740 · Ph 1 NCT02240212 · Ph 1 NCT02177682 · Ph 1 NCT02040480 · Ph 1 NCT01827644 · Ph 1 NCT01653912 · Ph 1/2 NCT01532700 · Ph 2 NCT01531894 · Ph 2 NCT01428492 · Ph 1 NCT01445587 · Ph 2 NCT01395004 · Ph 2 NCT01476137 · Ph 1

2012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 110 trials
Phase 1	NCT05489744	Aug → Oct 2022	—	Laekna Limited	Completed	No outcome recorded
Phase 1	NCT05390710	Jun 2021 → Dec 2023	triple-negative breast carcinoma	Laekna Limited	Completed	No outcome recorded
Phase 1	NCT02380313	Oct 2015 → May 2017	cancer	GlaxoSmithKline	Withdrawn	No outcome recorded Stop: Enrollment
Phase 1	NCT02235740	Nov 2014 → Oct 2015	cancer	Novartis	Terminated	No outcome recorded
Phase 1	NCT02240212	Oct 2014 → Feb 2017	cancer	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT02177682	Aug 2014 → Feb 2017	hematopoietic and lymphoid system neoplasm	Novartis Pharmaceuticals	Terminated	No outcome recorded
Phase 1	NCT02040480	Feb → Apr 2014	cancer	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01827644	Apr → Jul 2013	cancer	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01428492	Dec 2011 → Oct 2015	plasma cell myeloma	Novartis	Completed	No outcome recorded
Phase 1	NCT01476137	Oct 2011 → Mar 2013	cancer	GlaxoSmithKline	Completed	No outcome recorded
Phase 1/23 trials
Phase 1/2	NCT05383482	Jul 2022 → Jun 2024	cervical cancer, endometrial cancer, esophageal cancer, gastroesophageal adenocarcinoma +1	Laekna Limited	Completed	No outcome recorded
Phase 1/2	NCT04060394	Sep 2019 → Dec 2023	castration-resistant prostate carcinoma	Laekna Limited	Completed	No outcome recorded
Phase 1/2	NCT01653912	Nov 2012 → Jul 2015	—	Accenture	Completed	No outcome recorded
Phase 25 trials
Phase 2	NCT04374630	Jun 2020 → Jul 2023	refractory malignant neoplasm	Laekna Limited	Completed	No outcome recorded
Phase 2	NCT01531894	Feb 2012 → Jun 2018	cancer	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01532700	Feb 2012 → Jun 2017	B-cell chronic lymphocytic leukemia	University Health Network, Toronto	Completed	No outcome recorded
Phase 2	NCT01445587	Nov 2011	cancer	GlaxoSmithKline	Withdrawn	No outcome recorded
Phase 2	NCT01395004	Nov 2011 → Nov 2013	Langerhans cell histiocytosis	GlaxoSmithKline	Completed	No outcome recorded
Phase 31 trial
Phase 3	NCT04851613	Feb 2022 → Oct 2026 expected	breast cancer	Laekna Limited	Active not recruiting	No outcome recorded

News releases announcing trial results or a regulatory action · 14

Date	Issuer	Release
2026-08-12	Laekna Limited	Regulatory New Drug Application for LAE002 (afuresertib) Accepted by China’s National Medical Products Administration New Drug Application for LAE002 (afuresertib) Accepted by China’s National Medical Products Administration laekna.com ↗
2026-04-15	Laekna Limited	Results Positive Topline Results \| Laekna’s Phase III Clinical Trial of LAE002 (afuresertib) for Breast Cancer Met Primary Endpoint Positive Topline Results \| Laekna’s Phase III Clinical Trial of LAE002 (afuresertib) for Breast Cancer Met Primary Endpoint laekna.com ↗ The study met its primary endpoint, LAE002 (afuresertib) plus fulvestrant combination demonstrated a highly statistically significant and clinically meaningful improvement of PFS versus control.
2026-02-12	Laekna Limited	Results Nature Communications, February Issue \| Afuresertib Plus Fulvestrant Was Well Tolerated and Had Promising Anti-Tumor Activities Against Pretreated, Advanced HR-positive, Her2-negative Breast Cancer Nature Communications, February Issue \| Afuresertib Plus Fulvestrant Was Well Tolerated and Had Promising Anti-Tumor Activities Against Pretreated, Advanced HR-positive, Her2-negative Breast Cancer laekna.com ↗ The findings indicate that this combination regimen was well-tolerated and had promising antitumor activities against pretreated, advanced HR-positive, HER2-negative breast cancer.
2024-09-19	Laekna Limited	Results Laekna Announces Robust Phase 1b data of LAE002 (afuresertib) for treatment of HR+/ HER2- Breast Cancer at ESMO Congress 2024 Laekna Announces Robust Phase 1b data of LAE002 (afuresertib) for treatment of HR+/ HER2- Breast Cancer at ESMO Congress 2024 laekna.com ↗ Confirmed ORR was 33.3%, CBR was 66.7%, and the median PFS was 7.3 months
2024-08-07	Laekna Limited	Results Laekna Announces Significant Progress in a Triple-combination therapy (afuresertib plus Sintilimab plus nab-paclitaxel) in patients with specific solid tumors who were resistant to anti-PD-1/PD-L1 therapy and have been accepted for presentation at the 2024 Annual Global Meeting of IGCS Laekna Announces Significant Progress in a Triple-combination therapy (afuresertib plus Sintilimab plus nab-paclitaxel) in patients with specific solid tumors who were resistant to anti-PD-1/PD-L1 therapy and have been accepted for presentation at the 2024 Annual Global Meeting of IGCS laekna.com ↗ Positive response has been observed among the advanced cervical and endometrial cancer patients who have been treated multiple lines of SOCs including PD-1 drugs and/ or chemotherapy in the Phase I/II study.
2024-07-24	Laekna Limited	Results Laekna Announces Significant Progress on Clinical Developments Laekna Announces Significant Progress on Clinical Developments laekna.com ↗ Results of the Phase Ib study in all 31 patients and in a subgroup with PIK3CA/AKT1/PTEN alterations from U.S. and China have demonstrated promising anti-cancer efficacy with a well-tolerated safety profile.
2024-07-02	Laekna Limited	Results Investigator Meeting of Laekna AFFIRM-205(a phase III clinical study of breast cancer) Held in Beijing Investigator Meeting of Laekna AFFIRM-205(a phase III clinical study of breast cancer) Held in Beijing laekna.com ↗ As shown in the results of our phase Ib study, the median PFS of afuresertib plus fulvestrant was 7.3 months, which significantly improved from the PFS data of 3-4 months for fulvestrant monotherapy2.
2024-05-23	Laekna Limited	Regulatory Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of LAE002 (Afuresertib) PLUS LAE001 for the Treatment of Prostate Cancer Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of LAE002 (Afuresertib) PLUS LAE001 for the Treatment of Prostate Cancer laekna.com ↗
2024-04-09	Laekna Limited	Results AACR 2024 Presentation of Laekna \| Afuresertib Demonstrated Promising Treatment Benefit in Combination Therapy for Drug-resistant TNBC Patients AACR 2024 Presentation of Laekna \| Afuresertib Demonstrated Promising Treatment Benefit in Combination Therapy for Drug-resistant TNBC Patients laekna.com ↗ The combination therapy of afuresertib plus LAE005 and nab-paclitaxel is well tolerated and has demonstrated preliminary anti-tumor efficacy in locally advanced/metastatic TNBC who were resistant to prior chemotherapy, immune checkpoint inhibitor therapy, or PARP inhibitor therapy.
2023-12-11	Laekna Limited	Results 2023 SABCS│Laekna Reports Afuresertib Phase Ib Breast Cancer Study Results 2023 SABCS│Laekna Reports Afuresertib Phase Ib Breast Cancer Study Results laekna.com ↗ Among the total patient population, the confirmed ORR was 30% (95% CI, 11.9, 54.3), the median PFS was 7.3 months (95% CI, 3.7, NE).
2023-10-24	Laekna Limited	Results 2023 ESMO│Laekna (2105.HK) Announces Phase I/II Data of LAE001 plus afuresertib in mCRPC 2023 ESMO│Laekna (2105.HK) Announces Phase I/II Data of LAE001 plus afuresertib in mCRPC laekna.com ↗ The combination therapy demonstrated positive anti-tumor activity and safety in patients with mCRPC
2022-01-07	Laekna Limited	Regulatory Laekna Therapeutics and Innovent Biologics obtain IND approval for combination therapy in patients with specific types of solid tumors who have been refractory to treatment with PD-1/PD-L1 inhibitors Laekna Therapeutics and Innovent Biologics obtain IND approval for combination therapy in patients with specific types of solid tumors who have been refractory to treatment with PD-1/PD-L1 inhibitors laekna.com ↗
2021-09-16	Laekna Limited	Results Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress laekna.com ↗ The first study with LAE001 monotherapy targeting early stage of prostate cancer, and the second study with combination therapy of LAE001 + afuresertib in drug-resistant late stage prostate cancer, demonstrated positive and encouraging results by Laekna Therapeutics.
2021-08-26	Laekna Limited	Regulatory Laekna Therapeutics receives IND approvals in China and US for phase Ib/III global multi-center clinical study of afuresertib in combination with fulvestrant for patients with hr+/her2- breast cancer Laekna Therapeutics receives IND approvals in China and US for phase Ib/III global multi-center clinical study of afuresertib in combination with fulvestrant for patients with hr+/her2- breast cancer laekna.com ↗ Laekna Therapeutics announced today that the Center for Drug Evaluation (CDE), the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application of its Category 1 new drug candidate afuresertib (LAE002) in combination with anti-estrogen receptor drug fulvestrant in the Phase Ib/III clinical trial of patients with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

All press releases naming this drug 20 releases

Date	Issuer	Release
2026-08-12	Laekna Limited	New Drug Application for LAE002 (afuresertib) Accepted by China’s National Medical Products Administration New Drug Application for LAE002 (afuresertib) Accepted by China’s National Medical Products Administration laekna.com ↗
2026-04-15	Laekna Limited	Positive Topline Results \| Laekna’s Phase III Clinical Trial of LAE002 (afuresertib) for Breast Cancer Met Primary Endpoint Positive Topline Results \| Laekna’s Phase III Clinical Trial of LAE002 (afuresertib) for Breast Cancer Met Primary Endpoint laekna.com ↗
2026-02-12	Laekna Limited	Nature Communications, February Issue \| Afuresertib Plus Fulvestrant Was Well Tolerated and Had Promising Anti-Tumor Activities Against Pretreated, Advanced HR-positive, Her2-negative Breast Cancer Nature Communications, February Issue \| Afuresertib Plus Fulvestrant Was Well Tolerated and Had Promising Anti-Tumor Activities Against Pretreated, Advanced HR-positive, Her2-negative Breast Cancer laekna.com ↗
2025-12-15	Laekna Limited	Laekna announced completion of patient enrollment in phase III clinical trial (AFFIRM-205) of LAE002 (AFURESERTIB) in breast cancer Laekna announced completion of patient enrollment in phase III clinical trial (AFFIRM-205) of LAE002 (AFURESERTIB) in breast cancer laekna.com ↗
2025-11-12	Laekna Limited	Laekna entered into an exclusive licensing agreement with Qilu Pharma for LAE002 (AFURESERTIB), an innovative drug candidate for the treatment of breast cancer in China Laekna entered into an exclusive licensing agreement with Qilu Pharma for LAE002 (AFURESERTIB), an innovative drug candidate for the treatment of breast cancer in China laekna.com ↗
2024-09-19	Laekna Limited	Laekna Announces Robust Phase 1b data of LAE002 (afuresertib) for treatment of HR+/ HER2- Breast Cancer at ESMO Congress 2024 Laekna Announces Robust Phase 1b data of LAE002 (afuresertib) for treatment of HR+/ HER2- Breast Cancer at ESMO Congress 2024 laekna.com ↗
2024-08-07	Laekna Limited	Laekna Announces Significant Progress in a Triple-combination therapy (afuresertib plus Sintilimab plus nab-paclitaxel) in patients with specific solid tumors who were resistant to anti-PD-1/PD-L1 therapy and have been accepted for presentation at the 2024 Annual Global Meeting of IGCS Laekna Announces Significant Progress in a Triple-combination therapy (afuresertib plus Sintilimab plus nab-paclitaxel) in patients with specific solid tumors who were resistant to anti-PD-1/PD-L1 therapy and have been accepted for presentation at the 2024 Annual Global Meeting of IGCS laekna.com ↗
2024-07-24	Laekna Limited	Laekna Announces Significant Progress on Clinical Developments Laekna Announces Significant Progress on Clinical Developments laekna.com ↗
2024-07-02	Laekna Limited	Investigator Meeting of Laekna AFFIRM-205(a phase III clinical study of breast cancer) Held in Beijing Investigator Meeting of Laekna AFFIRM-205(a phase III clinical study of breast cancer) Held in Beijing laekna.com ↗
2024-05-30	Laekna Limited	Laekna Announces First Patient Enrolled in AFFIRM-205, a Phase III Clinical Study of LAE002 (afuresertib) Plus Fulvestrant for Treatment of Breast Cancer Laekna Announces First Patient Enrolled in AFFIRM-205, a Phase III Clinical Study of LAE002 (afuresertib) Plus Fulvestrant for Treatment of Breast Cancer laekna.com ↗
2024-05-23	Laekna Limited	Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of LAE002 (Afuresertib) PLUS LAE001 for the Treatment of Prostate Cancer Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of LAE002 (Afuresertib) PLUS LAE001 for the Treatment of Prostate Cancer laekna.com ↗
2024-04-09	Laekna Limited	AACR 2024 Presentation of Laekna \| Afuresertib Demonstrated Promising Treatment Benefit in Combination Therapy for Drug-resistant TNBC Patients AACR 2024 Presentation of Laekna \| Afuresertib Demonstrated Promising Treatment Benefit in Combination Therapy for Drug-resistant TNBC Patients laekna.com ↗
2023-12-11	Laekna Limited	2023 SABCS│Laekna Reports Afuresertib Phase Ib Breast Cancer Study Results 2023 SABCS│Laekna Reports Afuresertib Phase Ib Breast Cancer Study Results laekna.com ↗
2023-10-24	Laekna Limited	2023 ESMO│Laekna (2105.HK) Announces Phase I/II Data of LAE001 plus afuresertib in mCRPC 2023 ESMO│Laekna (2105.HK) Announces Phase I/II Data of LAE001 plus afuresertib in mCRPC laekna.com ↗
2023-09-22	Laekna Limited	Laekna Announces New Afuresertib Clinical Data in Breast Cancer to Be Presented at SABCS 2023 Laekna Announces New Afuresertib Clinical Data in Breast Cancer to Be Presented at SABCS 2023 laekna.com ↗
2022-05-26	Laekna Limited	Laekna Therapeutics Announces Dosing of First Patients in the U.S. and China in Phase Ib/III Study of Afuresertib in Combination with Fulvestrant in HR+/HER2- Breast Cancer Laekna Therapeutics Announces Dosing of First Patients in the U.S. and China in Phase Ib/III Study of Afuresertib in Combination with Fulvestrant in HR+/HER2- Breast Cancer laekna.com ↗
2022-01-07	Laekna Limited	Laekna Therapeutics and Innovent Biologics obtain IND approval for combination therapy in patients with specific types of solid tumors who have been refractory to treatment with PD-1/PD-L1 inhibitors Laekna Therapeutics and Innovent Biologics obtain IND approval for combination therapy in patients with specific types of solid tumors who have been refractory to treatment with PD-1/PD-L1 inhibitors laekna.com ↗
2021-09-16	Laekna Limited	Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress laekna.com ↗
2021-08-26	Laekna Limited	Laekna Therapeutics receives IND approvals in China and US for phase Ib/III global multi-center clinical study of afuresertib in combination with fulvestrant for patients with hr+/her2- breast cancer Laekna Therapeutics receives IND approvals in China and US for phase Ib/III global multi-center clinical study of afuresertib in combination with fulvestrant for patients with hr+/her2- breast cancer laekna.com ↗
2021-07-05	Laekna Limited	Laekna Therapeutics and Innovent enter a partnership agreement to co-develop combination therapy of afuresertib and sintilimab in clinical studies in China Laekna Therapeutics and Innovent enter a partnership agreement to co-develop combination therapy of afuresertib and sintilimab in clinical studies in China laekna.com ↗

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

Field	Value	Cited text
Known as	afuresertib	“GSK2110183 (afuresertib)” NCT01531894 ↗ 12 “Afuresertib (GSK2110183)” NCT02040480 ↗ NCT02380313 ↗ NCT02177682 ↗ NCT04060394 ↗ NCT01827644 ↗ NCT05390710 ↗ NCT04374630 ↗ NCT04851613 ↗ NCT02235740 ↗ NCT02240212 ↗ Show 2 more sources
Known as	AFU	“of afuresertib (AFU), in the fed and fasted state” NCT01827644 ↗
Known as	AFURESERTIB HYDROCHLORIDE	ChEMBL registry synonym — accepted as the source's own label CHEMBL2219422 ↗
Known as	ASB-183	ChEMBL registry synonym — accepted as the source's own label CHEMBL2219422 ↗
Known as	GSK-2110183B	ChEMBL registry synonym — accepted as the source's own label CHEMBL2219422 ↗
Known as	GSK-2110183C	ChEMBL registry synonym — accepted as the source's own label CHEMBL2219422 ↗
Known as	GSK2110183	“receive a single oral dose of 125mg GSK2110183” NCT01445587 ↗ 7 “Afuresertib (GSK2110183)” NCT02040480 ↗ NCT01653912 ↗ NCT01395004 ↗ NCT01532700 ↗ NCT01531894 ↗ NCT01476137 ↗ NCT01428492 ↗
Action	Inhibit	“Oral AKT Inhibitor GSK2110183” NCT01395004 ↗
Modality	Small molecule	“Oral AKT Inhibitor GSK2110183” NCT01395004 ↗ 1 CHEMBL2219422 ↗
Route	Oral	“GSK2110183 was orally administered at 125 mg once daily.” NCT01395004 ↗