Delving into the Latest Updates on Gedatolisib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Gedatolisib (USAN/INN), 格达托利西布, PF-05212384

+ [4]

Target

Akt x PI3Ks x mTORC1 x mTORC2

Action

inhibitors

Mechanism

Akt inhibitors(Proto-oncogene proteins c-akt inhibitors), PI3K family inhibitors(Phosphatidylinositol 3-kinase family inhibitors), mTORC1 inhibitors(Mammalian target of Rapamycin (mTORC1) inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication

Hormone receptor positive HER2 negative breast cancerMetastatic castration-resistant prostate cancerAdvanced Triple-Negative Breast Carcinoma+ [2]

Inactive Indication

Advanced cancerAdvanced Head and Neck CarcinomaAdvanced Lung Squamous Cell Carcinoma+ [14]

Originator Organization

Pfizer Inc.

Active Organization

Celcuity, Inc.

Pfizer Inc.

Inactive Organization-

License Organization

Celcuity, Inc.

Pfizer Inc.

Drug Highest PhaseApproved

First Approval Date

United States (14 Jul 2026),

Hormone receptor positive HER2 negative breast cancer

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States)

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Structure/Sequence

Molecular FormulaC32H41N9O4

InChIKeyDWZAEMINVBZMHQ-UHFFFAOYSA-N

CAS Registry1197160-78-3

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Start Date08 Dec 2022

Sponsor / Collaborator

Celcuity, Inc.

100 Clinical Results associated with Gedatolisib

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100 Translational Medicine associated with Gedatolisib

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100 Patents (Medical) associated with Gedatolisib

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134

Literatures (Medical) associated with Gedatolisib

01 Sep 2026·DRUGS

Emerging Strategies Targeting the PI3K/AKT/mTOR Pathway in HR+/HER2– Advanced Breast Cancer

Review

Author: Gandhi, Shipra ; Kalinsky, Kevin ; Canning, Madison ; Sakach, Elizabeth ; Kamga, Larisa ; Lei, Lan ; Abid, Minaam ; Lateef, Almeera

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer accounts for approximately 70% of breast cancer cases. Despite recent advances with cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), resistance inevitably develops, often driven by activation of the phosphatidylinositol 3-kinase (PI3K)-AKT-mammalian target of rapamycin (mTOR) pathway. Genetic alterations such as PIK3CA mutations (present in ~ 45% of HR+/HER2- tumors), AKT1 mutations, and PTEN loss contribute to endocrine resistance and poor outcomes. This review summarizes emerging strategies targeting this pathway to overcome resistance in advanced disease. Isoform-specific PI3K inhibitors, including alpelisib and inavolisib, have demonstrated clinically meaningful progression-free survival benefits in PIK3CA-mutated populations, with inavolisib showing improved tolerability and efficacy. In contrast, pan-PI3K inhibitors such as buparlisib have been constrained by toxicity. Targeting downstream signaling, AKT inhibitors have also shown benefit: capivasertib has demonstrated clinical efficacy leading to US Food and Drug Administration approval, while ipatasertib has yielded encouraging results, particularly in tumors harboring PIK3CA, AKT1, or PTEN alterations. Mammalian target of rapamycin inhibitors, notably everolimus, have shown efficacy irrespective of mutation status. The dual PI3K-mTOR inhibitor (gedatolisib) has also shown promising progression-free survival benefit in a PIK3CA wild-type population. Next-generation agents, including mutant-selective PI3Kα inhibitors and bi-steric mTOR complex 1 inhibitors, are under active investigation. Optimal sequencing of these agents alongside endocrine therapy and CDK4/6i options remain a critical question, as does integration of genomic testing to guide therapy. Future directions include rational combination strategies, improved biomarker-driven selection, and novel modalities such as proteolysis-targeting chimeras (PROTACs). Collectively, these advances aim to enhance durability of response, minimize toxicity, and improve survival in HR+/HER2- metastatic breast cancer.

01 Sep 2026·ESMO Open

Corrigendum to ‘Phase II study of trastuzumab-pkrb plus gedatolisib in patients with HER2-positive metastatic breast cancer who progressed after two or more HER2-directed therapies’

Author: Kim, J H ; Bae, J ; Kim, H J ; Ko, S ; Lee, G W ; Jung, J Y ; Kim, J E ; Lee, E M ; Kwon, J H ; Oh, S Y ; Kim, J W ; Park, S ; Kang, M J ; Choi, J Y ; Ahn, H K ; Lee, K-H ; Park, K U ; Park, J H ; Kim, T H ; Chae, Y S ; Chae, H ; Park, Y H ; Lee, K E ; Park, I H ; Byun, J H ; Lee, S ; Ha, J Y ; Park, K H ; Kim, M H

01 Jul 2026·ESMO Open

Phase II study of trastuzumab-pkrb plus gedatolisib in patients with HER2-positive metastatic breast cancer who progressed after two or more HER2-directed therapies

Article

Author: Kim, J H ; Bae, J ; Kim, H J ; Ko, S ; Lee, G W ; Jung, J Y ; Kim, J E ; Lee, E M ; Kwon, J H ; Oh, S Y ; Park, S ; Kim, J W ; Kang, M J ; Choi, J Y ; Ahn, H K ; Lee, K-H ; Park, K U ; Park, J H ; Chae, Y S ; Kim, T H ; Chae, H ; Park, Y H ; Park, I H ; Lee, K E ; Byun, J H ; Lee, S ; Ha, J Y ; Park, K H ; Kim, M H

BACKGROUND:

To evaluate the activity and safety of trastuzumab-pkrb plus gedatolisib in patients with treatment-refractory human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) harboring phosphatidylinositol 3-kinase (PI3K) pathway alterations.

PATIENTS AND METHODS:

In this multicenter, single-arm phase II study, eligible patients had HER2-positive MBC with PI3K pathway aberrations identified by tumor or circulating cell-free DNA and had progressed after at least two prior HER2-directed therapies. Patients received trastuzumab-pkrb (8 mg/kg loading dose, then 6 mg/kg IV every 3 weeks) plus gedatolisib (180 mg IV on days 1, 8 and 15 of each 21-day cycle). The primary endpoint was objective response rate (ORR), 90% power with one-sided 5% type I error, assuming a 25% target for the combination therapy. The trial closed early after 44 patients due to changes in regulatory sponsorship.

RESULTS:

PI3K pathway alterations included PIK3CA kinase domain mutations (59%), helical domain mutations (25%), and PTEN deletions (5%). The ORR was 43.2% [95% confidence interval (CI) 28.3%-59.0%], with two complete and 17 partial responses. Disease control rate was 86.4%. Median progression-free survival (PFS) was 6.01 months (95% CI 5.03-7.69), and median overall survival (OS) was 24.74 months (95% CI 17.28-NA) after 32.05 months of follow-up. Oral mucositis (90.9%; 15.9% grade ≥3) and hyperglycemia (25.0%; 2.3% grade 3) were most frequent, and no treatment-related deaths occurred. Early circulating tumor DNA dynamics predicted PFS and OS.

CONCLUSION:

Trastuzumab-pkrb plus gedatolisib demonstrated a 43.2% response rate and manageable toxicity, supporting dual HER2/PI3K pathway targeting in heavily pretreated HER2-positive MBC.

134

News (Medical) associated with Gedatolisib

19 Oct 2026

·www.biospace.com

Faeth to Present Preclinical Data on PIKTOR in HR+/HER2- Breast Cancer Models at ESMO 2026

Poster will characterize the efficacy of PIKTOR as a monotherapy and in combination with fulvestrant, oral SERDs, and CDK inhibitors in preclinical models of breast cancer Poster also includes results from head-to-head comparisons with gedatolisib, another multi-nodal inhibitor of the PI3K-AKT-mTOR (PAM) pathway, in preclinical breast cancer xenograft models The poster will be presented on Friday, October 23 at 15:15 CEST (9:15 a.m. ET). These preclinical data are intended to inform ongoing clinical development in the FTH-PIK-101 trial AUSTIN, Texas--(BUSINESS WIRE)--Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, today announced that it will present preclinical data at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. The poster will be presented on Friday, October 23, and will showcase preclinical data intended to inform the ongoing development of PIKTOR in the FTH-PIK-101 Phase 1b/2 trial in HR+/HER2- breast cancer. In the poster, PIKTOR is tested as monotherapy and in combination with fulvestrant, oral SERDs and CDK inhibitors, which are standard and emerging treatments for patients with HR+ breast cancer. Data from mouse xenograft models will be accompanied by cellular assays showing that in these preclinical models, PIKTOR suppressed key signaling nodes in the PAM pathway, including AKT, at rates comparable to or exceeding those observed with tested single-node inhibitors. The poster also compares PIKTOR head-to-head with gedatolisib in two preclinical breast cancer xenograft models. A copy of the poster will be made available in the Investors section of Faeth’s website at the start of the poster session. Presentation Details: Title: Characterising the efficacy of multi-node PI3K/AKT/mTOR pathway inhibition with serabelisib and sapanisertib (PIKTOR) in combination with SERDs and CDK inhibitors in models of HR+/HER2- breast cancer Abstract Number: 431P Session: Basic Science Poster Session Date: Friday, October 23, 2026 Location: Poster Area - Hall 5 Time: 15:15 - 16:00 CEST (9:15 - 10:00 a.m. ET) Presenter: Oliver Maddocks, Ph.D., Co-Founder & Chief Scientific Officer of Faeth Therapeutics About PIKTOR PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. This multi-node approach is designed to address the signaling feedback reactivation and treatment-emergent resistance mutations that may limit the efficacy of single-node PI3K/AKT/mTOR pathway inhibitors. According to published literature, the PAM pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027. About Faeth Therapeutics Faeth Therapeutics, Inc. (Nasdaq: FTH) is a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways. The Company’s lead program is PIKTOR, an investigational all-oral combination of serabelisib and sapanisertib in development for endometrial and breast cancer. Faeth was co-founded in 2019 by Anand Parikh and Oliver Maddocks, Ph.D., together with scientific founders Lewis Cantley, Ph.D., the discoverer of the PI3K pathway; Siddhartha Mukherjee, M.D., D.Phil.; Karen Vousden, Ph.D.; Scott Lowe, Ph.D.; and Greg Hannon, Ph.D. The Company intends to use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, please visit and follow the Company on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the federal securities laws, including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “plan,” “may,” “will,” “would,” “could,” “should,” “estimate,” “potential,” “target,” “on track” and similar expressions, although not all forward-looking statements contain these words. These statements include, but are not limited to, statements regarding: the content, timing and presentation of data at the ESMO Congress 2026, including head-to-head comparisons with gedatolisib; the Company’s interpretation of preclinical data and the conclusions the Company draws from that data; the Company’s expectations regarding its pipeline and development plans, including the Phase 2 trial of PIKTOR in advanced endometrial cancer and the anticipated timing of topline data, and the Phase 1b/2 trial of PIKTOR in HR+/HER2- advanced breast cancer and the anticipated timing of interim data; and the potential therapeutic benefits, tolerability pro differentiation of PIKTOR. Forward-looking statements are based on management’s current expectations and assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, risks related to clinical development and the conduct, timing and results of clinical trials; the risk that results from preclinical studies, including comparisons with other product candidates or approved products, may not be predictive of results in ongoing or future clinical trials; the Company’s need for additional financing; its limited operating history and history of operating losses; risks related to the integration of Faeth; the Company’s ability to satisfy applicable Nasdaq listing requirements and to maintain the listing of its common stock; and the other risks and uncertainties described under the headings “Risk Factors” and “Summary of Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2026, its Quarterly Report on Form 10-Q filed with the SEC on August 4, 2026, and its definitive proxy statement filed with the SEC on April 27, 2026, as well as in the Company’s subsequent filings. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required by law. Contacts Investor Contact: Matthew Biegler, SVP, Investor Relations matt@faeththerapeutics.com Media Contact: Patrick Schmidt, Consort Partners faeththerapeutics@consortpartners.com

Phase 2

06 Oct 2026

·firstwordpharma.com

KymaThera nabs $80M to move PI3Kα inhibitor into the clinic

KymaThera closed an $80-million series B on Tuesday to fill what it sees as a PI3Kα-sized hole in cancer care, despite several approved treatments. The round, led by Alta Partners, builds on the biotech's 2024 series A and brings its total capital raised to date to more than $100 million. Other investors in the latest financing include Venrock, Foresite Capital and J. Wood Capital. "PI3Kα is one of the most important, well-validated, and heavily pursued disease drivers in oncology, but its therapeutic potential has been constrained by wild-type PI3Kα-mediated toxicity and incomplete coverage of clinically relevant mutations," KymaThera CEO Rob Kania said in a company release. "Our drug design objective from the outset was to address these limitations."At least three PI3Kα-targeting treatments are approved in the US, including Novartis' Piqray (alpelisib) and Roche's Itovebi (inavolisib), both cleared for HR-positive, HER2-negative breast cancer patients with a PI3KCA mutation. Celucity's Revtorpyk (gedatolisib), a comprehensive inhibitor of the PI3K/AKT/mTOR (PAM) pathway, was greenlit by the FDA in July for patients with HR-positive, HER2-negative breast cancer who lack a PIK3CA mutation. In addition to Piqray, Novartis recently upped its commitment to the target by splashing $2 billion upfront to buy Pikavation Therapeutics and its portfolio of pan-mutant selective PI3Kα inhibitor programmes. 'Class-leading potency'KymaThera plans to use the fresh funding to move its lead candidate K-1728 into Phase I testing this quarter and advance it through initial clinical proof-of-concept. Initially, the biotech said it plans to develop the oral, pan-mutant selective PI3Kα inhibitor as a monotherapy and in combination regimens for HR-positive, HER2-negative breast cancer, "where substantial unmet need remains despite available therapies." It will also explore K-1728's potential to treat PI3Kα-driven vascular malformations as a monotherapy. Leveraging its structure-based drug discovery technology, KymaThera designed K-1728 to address the limitations of first-generation PI3Kα inhibitors by blocking disease-driving kinase and helical domain mutations while preserving wild-type PI3Kα.KymaThera said that in preclinical studies using models with both kinase and helical domain PI3Kα mutations, low, once-daily doses of K-1728 led to tumour regressions. "K-1728 possesses class-leading potency with helical mutant selectivity windows wider than any reported to date," Kania said.

Drug ApprovalPhase 1Acquisition

05 Oct 2026

·www.biospace.com

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Rapid oral presentation of additional sub-group analyses from the VIKTORIA-1 PIK3CA mutant-type cohort Poster presentation of a comparative analysis of data for the gedatolisib triplet from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer Poster presentation of sub-group analyses from the Phase 1b trial of gedatolisib plus darolutamide in patients with mCRPC MINNEAPOLIS, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that a late breaking rapid oral presentation and three poster presentations will be featured at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2026 being held October 23-27, 2026, in Madrid, Spain. Data from its clinical trials of gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”) and metastatic castration-resistant prostate cancer (“mCRPC”) will be presented. Late Breaking Rapid Oral Presentation Details: Title: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2) Presentation Number: LBA 16 Speaker: Barbara Pistilli, MD Session Title: Rapid oral 1: Breast cancer, advanced stage Room: Almeria Auditorium - Hall 9 Date: Saturday, October 24, 2026 Time: 10:15 –11:45 a.m. CEST Poster Presentation Details: Title: A phase 1/2, open-label, randomized, dose-finding and dose expansion study of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) Presentation Numbe r : 2237P Presenting Author: Adam Sharp, MD, PhD Session Title: Poster Display session, Metastatic prostate cancer Date: Friday, October 23, 2026 Time: 3:15 p.m. – 4:00 p.m. CEST Title: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA) Presentation Numbe r : 1873P Presenting Author: Sara Tolaney, MD Session Title: Poster Display session, HR+ breast cancer Date: Saturday, October 24, 2026 Time: 12:00 p.m. – 12:45 p.m. CEST Title: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib with Endocrine Therapy (ET) and Palbociclib vs ET and Ribociclib as First-Line (1L) Treatment in Patients With HR-Positive (HR+) HER2-Negative (HER2-) Advanced Breast Cancer (ABC) (VIKTORIA-2) Presentation Numbe r : 57TiP Presenting Author: Giuseppe Curigliano, MD, PhD Session Title: Poster Display session, Advanced breast cancer, other Date: Saturday, October 24, 2026 Time: 12:00 p.m. – 12:45 p.m. CEST Abstracts will be published online via the ESMO website at 12:05 a.m. CEST on October 19, 2026. The posters will be presented in the Poster Area – Hall 5. Electronic versions will also be available on the ESMO 2026 virtual platform. About Celcuity Celcuity is a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK™ (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Follow us on LinkedIn and X . Contacts: For Investors: Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 For investors and media: Jodi Sievers, jsievers@celcuity.com (415) 494-9924

Phase 1Phase 3Drug ApprovalPhase 2Clinical Result

100 Deals associated with Gedatolisib

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External Link

KEGG	Wiki	ATC	Drug Bank
D10635	Gedatolisib	-	DB11896

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	United States	Celcuity, Inc.	14 Jul 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	United States	Celcuity, Inc.	01 Jan 2024
Metastatic castration-resistant prostate cancer	Phase 2	France	Celcuity, Inc.	01 Jan 2024
Metastatic castration-resistant prostate cancer	Phase 2	Spain	Celcuity, Inc.	01 Jan 2024
Metastatic castration-resistant prostate cancer	Phase 2	United Kingdom	Celcuity, Inc.	01 Jan 2024
Advanced Triple-Negative Breast Carcinoma	Phase 2	United States	Pfizer Inc.	17 Apr 2019
HER2-negative breast cancer	Phase 2	United States	Pfizer Inc.	17 Apr 2019
Triple Negative Breast Cancer	Phase 2	United States	Pfizer Inc.	17 Apr 2019
Breast cancer recurrent	Phase 2	United States	Pfizer Inc.	26 Feb 2019
Early Stage Breast Carcinoma	Phase 2	United States	Pfizer Inc.	26 Feb 2019
metastatic non-small cell lung cancer	Phase 2	United States	Pfizer Inc.	25 Sep 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06757634 (VIKTORIA-2, ESMO2026)	Phase 3	HR Positive/HER2 Negative/Node positive breast cancer First line HR-Positive \| HER2-negative	368	Gedatolisib + Fulvestrant + Palbociclib	vtyikhghvg(clbczfjvnq) = jatnfqjlrh xxdmalujyc (lnaolzoxpq, 36.1 - NR) View more	Positive	23 Oct 2026
				Fulvestrant + Ribociclib	cqjhhuiwjn(pjnaubbdzv) = nzcrthemnq wjzwgcgoho (busjawwvvo )
VIKTORIA-1 (ESMO_BC2026)	Phase 3	Advanced breast cancer Second line HR+ \| HER2- \| PIK3CA-Wild Type	392	Gedatolisib + Palbociclib + Fulvestrant	vogxlevdnk(usxgqkurea) = objcatmplo pzopmcsmpl (bqfkjyqbzn )	Positive	07 May 2026
				Fulvestrant	vogxlevdnk(usxgqkurea) = rlufoaywxk pzopmcsmpl (bqfkjyqbzn ) View more
VIKTORIA-1 (ESMO_BC2026)	Phase 3	Advanced breast cancer Second line HR+ \| HER2- \| PIK3CA-Wild Type	325	Gedatolisib + Palbociclib + Fulvestrant	qomabmomhg(iwamygsnvk) = tsbdqjujqs loybkffulu (urcpbyqxjz )	Positive	07 May 2026
				Gedatolisib + Fulvestrant	qomabmomhg(iwamygsnvk) = xopalykmqa loybkffulu (urcpbyqxjz )
NCT05501886 (VIKTORIA-1, Pubmed \| J Clin Oncol)	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer hormone receptor-positive \| HER2− \| PIK3CA wild-type	392	Gedatolisib + Palbociclib + Fulvestrant	zefhxalqbe(sqonhjvcnd) = nqiwdiawjy wmmpmedqwk (uqtkmaudqp ) View more	Positive	20 Apr 2026
				Gedatolisib + Fulvestrant	zefhxalqbe(sqonhjvcnd) = scwliuvyyo wmmpmedqwk (uqtkmaudqp ) View more
NCT05501886 (VIKTORIA-1, J Clin Oncol \| Biospace) Manual	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer Hormone Receptor–Positive \| HER2− \| PIK3CA Wild-Type	392	gedatolisib+palbociclib+fulvestrant	ynqtktgodk(jjqxyyyyse) = fwlpnaezgw xcjyhsgzje (yuihdgkyvf ) Met View more	Positive	09 Mar 2026
				gedatolisib+fulvestrant	ynqtktgodk(jjqxyyyyse) = euwdscjaud xcjyhsgzje (yuihdgkyvf ) Met View more
NCT06190899 (ASCO_GU2026)	Phase 1/2	Metastatic castration-resistant prostate cancer	56	Gedatolisib 120 mg + Darolutamide	jzpvglfizi(pgaqeqzlrn) = jpmlqbyvnx afdugwlcei (mvdhrfosjl ) View more	Positive	26 Feb 2026
				Gedatolisib 180 mg + Darolutamide	isgijwhuoj(xxxuqcmpou) = bypdmfjvtd khbadoqyst (yktvawizpq ) View more
VIKTORIA-1 (ESMO2025)	Phase 3	Advanced breast cancer Second line HR+ \| HER2- \| PIK3CA wild-type	392	Gedatolisib + Palbociclib + Fulvestrant	ssxfvwxbad(vjxcxbnqas) = adoukdknkg fnglndbmmn (qqkciqmezf ) View more	Positive	17 Oct 2025
				Gedatolisib + Fulvestrant	ssxfvwxbad(vjxcxbnqas) = rxffxfuytf fnglndbmmn (qqkciqmezf ) View more
Pubmed \| Clin Cancer Res Manual	Phase 1	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2−	41	Gedatolisib + Palbociclib + Letrozole	euodhhmvgb(kuzvtshywe) = hdqwcaoxzr origxmyhyt (cqskrtmwnq ) View more	Positive	20 Aug 2025
NCT05501886 (VIKTORIA-1, PipelineReview \| NEWS) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive \| PIK3CA Gene Mutation Negative	-	Gedatolisib Gedatolisib + palbociclib + fulvestrant	hvhyweiehl(wrgjyqkans) = kytflhhxrs kdeynokazx (lpmljdkxaz ) View more	Positive	28 Jul 2025
				Gedatolisib Gedatolisib + fulvestrant	hvhyweiehl(wrgjyqkans) = zekvggaooi kdeynokazx (lpmljdkxaz )
NCT03911973 (Pubmed \| Breast Cancer Res Treat) Manual	Phase 1/2	Advanced Triple-Negative Breast Carcinoma \| BRCA mutation positive Breast Cancer HER2 Negative \| ER Negative \| PR Negative ... View more	-	Gedatolisib + Talazoparib	qfiaauiwam(lbciohjquu) = wglbaskpuv catambfchy (hhmtnwghqe ) View more	Negative	05 Jun 2025