The goal of this clinical trial is to learn if alisertib in addition to usual care works to treat HR+/HER2+ breast cancer. The main questions it aims to answer are:
* Does alisertib stop the communication between HR and HER2?
* Are there genetic markers that predict how well someone's cancer will respond to alisertib?
Participants will receive alisertib in addition to their usual care.

Start Date01 Oct 2026

Sponsor / Collaborator

University of Wisconsin-Madison

NCT07465757

/ RecruitingPhase 2

A Phase 2 Study of Alisertib in Combination With Paclitaxel in Patients With Small Cell Lung Cancer

The goal of this clinical trial is to determine how well people tolerate treatment with alisertib at different doses when it is used together with paclitaxel to treat people with SCLC. The main question it aims to answer is:
* What percentage of side effects, both mild and serious, do participants experience when being treated with alisertib and paclitaxel based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0)?
The study will consist of different groups, called cohorts, in which alisertib will be studied at increasing doses. Participants in the first group, Cohort 1, will take 30 mg of alisertib by mouth 2 times a day. The dose will increase by 10 mg 2 times a day for each new cohort of participants joining the study. Side effects will be checked during the study, and the decision to increase the dose of alisertib will be based on the specific side effects experienced during the first 21 days of treatment for each cohort.
Participants will:
* take alisertib by mouth on their own 2 times a day from Day 1 through Day 7 of each 21-day cycle and will be given paclitaxel intravenously at a dose of 60 mg/m2 on Day 1 and Day 8 of each 21-day cycle.
* be given a preventive treatment to increase their body defenses, called granulocyte-colony stimulating factor (G-CSF). Study staff will give G-CSF after the last dose of alisertib or paclitaxel of each 21-day cycle in which alisertib was given.
* provide blood samples to evaluate the different levels of alisertib in the blood at different times. Blood samples will be collected on Days 1 and 7 of the first and second 21-day cycles of treatment.
* be treated with alisertib and paclitaxel until death, worsening of the disease, unacceptable toxicity, unwillingness to continue participating in the trial, or other criteria that requires participants to stop treatment and participation in the study.
* be contacted every 8 weeks after stopping alisertib and paclitaxel treatment as part of a specific study phase called the long-term follow-up period. This will last until death, unwillingness to continue participating in the trial, or until the end of the study.

Start Date17 Sep 2026

Sponsor / Collaborator

Puma Biotechnology, Inc.

NCT06369285

/ RecruitingPhase 2

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.

Start Date19 Nov 2024

Sponsor / Collaborator

Puma Biotechnology, Inc.

100 Clinical Results associated with Alisertib

100 Translational Medicine associated with Alisertib

100 Patents (Medical) associated with Alisertib

522

Literatures (Medical) associated with Alisertib

01 Feb 2027·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Integrative Systems Biology Prioritizes BCL2, ALK, and CDK4 as Therapeutic Candidates in Neuroblastoma through Multi‐Centrality Network Analysis, Cross‐Database Validation, Independent Docking Validation, and Confidence‐Threshold Sensitivity Analysis

Article

Author: Zabihi, Abbas

BACKGROUND:

Neuroblastoma remains a therapeutic challenge due to its molecular heterogeneity, yet the convergent network topology of its oncogenic interactome has not been systematically characterized using multi-criteria computational approaches. An integrative computational framework combining network-based hub gene prioritization, cross-database biological validation, and structure-based drug-target assessment is needed to identify and prioritize therapeutic molecular targets.

METHODS:

An integrative computational pipeline was developed comprising (i) batch-effect correction (ComBat) and differential expression analysis of two neuroblastoma microarray datasets (GSE10927, GSE16476); (ii) protein-protein interaction (PPI) network reconstruction (STRING v11.5) and multi-criteria candidate identification using six complementary centrality metrics (degree, betweenness, closeness, MCC, MNC, EPC); (iii) modular decomposition (Louvain algorithm) and functional enrichment analysis (GO, KEGG, WikiPathways); (iv) miRNA regulatory network analysis (DIANA-miRPath/TarBase); (v) independent cross-validation against six external databases (TARGET-NBL, Human Protein Atlas, CCLE, DepMap, GDSC, cBioPortal); (vi) molecular docking (HDOCK) and 100-ns molecular dynamics simulations (one trajectory per complex) with trajectory analysis (RMSD, RMSF, Rg, hydrogen-bond occupancy); and (vii) two revision-stage verification analyses: an independent AutoDock Vina re-docking validation of the five drug-target pairs and their co-crystallized ligands, and a confidence-threshold sensitivity analysis of the PPI network (0.400/0.700/0.900) computed on the version-locked STRING v11.5 release restricted to the exported hub node set.

RESULTS:

The batch-corrected transcriptomic integration effectively separated tumors from normal samples (PCA, 82.9% variance explained). Multi-criteria network analysis prioritized BCL2, ALK, MYCN, CDK4, and MAPT as leading candidates. Modular decomposition revealed seven functional clusters spanning cell cycle regulation, apoptosis, MAPK signaling, and neuronal differentiation. BCL2, ALK, and CDK4 showed multi-database validation concordance: transcriptomic overexpression (TARGET-NBL, log2FC = 1.84 for BCL2, FDR < 0.001), protein-level confirmation (Human Protein Atlas), selective gene dependency (DepMap CRISPR), and pharmacogenomic sensitivity (GDSC). miRNA network analysis identified miR-34a as a master post-transcriptional regulator targeting BCL2, CDK4, and MYCN simultaneously. The original HDOCK docking and 100-ns MD analyses (one trajectory per complex) supported predicted binding stability for BCL2/Venetoclax (HDOCK score: -271.19), ALK/Ceritinib (-222.91), and CDK4/Abemaciclib (-219.76). The revision-stage sensitivity analysis showed that hub-hub connectivity is strongly threshold-dependent (508, 138, and 48 interactions among the exported hub nodes at confidence ≥ 0.400, 0.700, and 0.900), and that the centrality of the three priority genes is sensitive to network stringency; they are therefore described as computationally prioritized candidates rather than threshold-robust hubs. The independent Vina validation recovered the native binding sites of all five targets (top-pose centroid offsets 0.15-2.6 Å) with favorable scores for every drug-target pair (-12.3 to -6.4 kcal/mol), while pose-level RMSD values (4.8-7.3 Å) showed that rigid-receptor docking does not resolve exact ligand orientations for these flexible inhibitors; docking scores are therefore interpreted as site-level binding-competence evidence only.

CONCLUSIONS:

This study presents an integrative computational pipeline for network-based drug-target prioritization in neuroblastoma, combining multi-criteria network topology, multi-database biological validation, HDOCK docking with single-trajectory MD stability assessment, and two independent revision-stage verification analyses (AutoDock Vina re-docking and confidence-threshold sensitivity). Within the explicitly reported boundaries of these analyses, BCL2, ALK, and CDK4, together with the AURKA and beta-tubulin axes of Alisertib and Docetaxel, emerge as computationally prioritized candidates for preclinical investigation, with replicate MD simulations on high-performance computing resources and experimental target engagement identified as the required next steps.

01 Oct 2026·JOURNAL OF CONTROLLED RELEASE

Nanoparticles-mediated dual drug administration boosts therapeutic efficacy in drug resistant melanoma

Article

Author: Tiboni, Mattia ; Prandini, Federica Maria ; Casettari, Luca ; Gatti, Lodovico ; Brambilla, Luca ; Beccalli, Martina ; Mileti, Erika ; Fossati, Paolo ; Baldelli Bombelli, Francesca ; Sigismund, Sara ; Duca, Daria ; Benvenuto, Andrea Francesco ; Milesi, Pietro ; Marocchi, Federica ; Giardina, Giuseppina ; Jodice, Giovanna ; Lanfrancone, Luisa ; Doni, Mirko ; Barberis, Massimo ; Lovati, Giulia

Metastatic melanoma remains a critical clinical challenge due to high transcriptional plasticity and the physical barriers of the tumor microenvironment that limit the efficacy of standard therapies. In this study, we present a microfluidic-engineered poly(lactic-co-glycolic acid) nanoparticle (PLGA-NPs) platform designed to maximize therapeutic efficacy through the precise co-encapsulation of synergistic drug combinations. These monodisperse nanocarriers exhibit rapid, dose-dependent internalization across diverse patient-derived models, independent of their mutational background. Mechanistically, we demonstrate that PLGA-NPs uptake is primarily mediated by dynamin-dependent endocytosis and macropinocytosis, followed by a dynamic intracellular trafficking route that reaches a steady-state distribution within recycling endosomes, thereby enabling prolonged intracellular cargo retention. In 3D patient-derived spheroids, these nanoparticles exploit active cell-to-cell transfer consistent with a transcytosis-like mechanism to penetrate the poorly accessible central core, effectively bypassing tissue-level resistance and considerably enhancing drug efficacy. In vivo biodistribution in orthotopically transplanted patient-derived xenografts confirmed highly efficient tumor targeting, while a strategic dose-modulation approach successfully optimized the tumor-to-liver accumulation ratio. Therapeutically, twice-weekly intravenous administration of trametinib-loaded NPs achieved superior tumor regression and significantly prolonged overall survival compared to daily oral administration of the free drug. Furthermore, we developed a dual-drug delivery system co-loading trametinib, MEK inhibitor, and alisertib, Aurora kinase A inhibitor. This formulation was optimized to maintain a previously established synergistic ratio which effectively overcomes acquired resistance to standard-of-care therapies and induces durable tumor regression. Collectively, these findings establish the PLGA-NPs platform as a robust, clinically relevant strategy to enhance the pharmacokinetic profile of treatments for metastatic and drug-resistant melanoma.

01 Sep 2026·DRUG DEVELOPMENT RESEARCH

Thiadiazolo‐Triazolo‐Pyrimidine Hybrids as Dual Aurora A/ERK Inhibitors: Design, Synthesis, and Apoptotic Activity

Article

Author: Hofni, Amal ; Mourad, Ahmed A. E. ; Mourad, Mai A. E.

ABSTRACT:

Aberrant activation of Aurora A kinase causes mitotic spindle assembly, chromosome segregation, and cell cycle progression, leading to genomic instability as well as disruption of several tumor suppressors. Furthermore, ERK has largely emerged as a survival signaling pathway controlling cell proliferation, differentiation, and metastasis. Unfortunately, this pathway is overexpressed in most of the human malignancies. In efforts to develop innovative inhibitors targeting Aurora A/ERK signaling pathway, a novel series of thiadiazolo‐, triazolo‐pyrimidine hybrids have been designed, synthesized, and assessed for their ability to block Aurora A/ERK and induce apoptosis. Cytotoxicity of the synthesized hybrids was examined against MCF‐7, HCT‐116 and A549 cell lines. Among the synthesized hybrids, 9a , 9c , and 14b demonstrated higher cytotoxic action than alisertib and GDC‐0994 against the MCF‐7 and A549 cancer cell lines. IC 50 values for these hybrids were 2.59 ± 0.13, 4.63 ± 0.25, and 5.77 ± 0.38, respectively, against MCF‐7 cell line and were 3.61 ± 0.19, 3.85 ± 0.21, and 4.23 ± 0.15, respectively, against A549. The selected hybrids significantly suppressed p‐Aurora A kinase level as well as p‐ERK1/2 level and its upstream regulators p‐SRC, p‐c‐RAF, p‐MEK1/2; meanwhile, ERK downstream effectors FOXO3a level was upregulated, and c‐Myc was downregulated, in a dose‐dependent manner. The selected hybrids significantly decreased the expression of Bcl‐2 protein while increasing the levels of p53 , caspase‐7, caspase‐9, and Bax. They effectively induced pre‐G1 phase, G0/G1 phase apoptosis, and G2/M phase arrest. The synthesized hybrids possessed favorable binding interactions in the molecular docking investigations as well as appropriate drug‐like characteristics.

News (Medical) associated with Alisertib

23 Oct 2026

·www.biospace.com

Puma Biotechnology to Host Conference Call to Discuss Third Quarter 2026 Financial Results

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PT/4:30 p.m. ET on Thursday, November 5, 2026, following the release of its third quarter 2026 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX ® was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX ® was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. In September 2026, Puma initiated ALISCA ® -Lung2, a Phase II clinical trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at . Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com

Drug ApprovalLicense out/inPhase 2Phase 1Financial Statement

06 Oct 2026

·www.biospace.com

Puma Biotechnology Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4) - October 5, 2026

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on October 1, 2026, the Compensation Committee of Puma’s Board of Directors approved the grant of an inducement restricted stock unit award covering 7,500 shares of Puma common stock to one new non-executive employee. The award was granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017, and provides for the granting of equity awards to new employees of Puma. The restricted stock unit award vests over a three-year period, with one-third of the shares underlying the award vesting on the first anniversary of the award’s vesting commencement date, October 1, 2026, and one-sixth of the shares underlying the award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The award was granted as an inducement material to the new employee entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4). About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. In September 2026, Puma initiated ALISCA ® -Lung2, a Phase II clinical trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com

Drug ApprovalLicense out/inPhase 2

17 Sep 2026

·www.biospace.com

Puma Biotechnology Initiates ALISCA®-Lung2, a Phase II Trial of Alisertib in Combination with Paclitaxel for the Treatment of Patients with Advanced Small Cell Lung Cancer

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA ® -Lung2) Phase II trial (PUMA-ALI-4202; NCT07465757 ) of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. The ALISCA ® -Lung2 trial is a sequential dose escalation study that will enroll approximately 50 patients with small cell lung cancer who have progressed on or after treatment with platinum-based chemotherapy and immunotherapy. The primary endpoint of the trial is the safety and tolerability of alisertib when administered with paclitaxel. Secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival and overall survival. Puma will also evaluate clinical biomarkers to help identify which patients have the greatest benefit to guide the future development of alisertib. Taofeek K. Owonikoko, MD, PhD and Chair of the trial’s Steering Committee, said, “Treatment options for patients with small cell lung cancer that has progressed following platinum-based chemotherapy and immunotherapy remain limited, and there is an urgent need for new treatment approaches for these patients. I am pleased to see further evaluation of alisertib in these patients." Dr. Owonikoko is the Executive Director of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, and the Kevin J. Cullen, MD Distinguished Professor of Oncology at the University of Maryland School of Medicine. He added, “The results from previous clinical trials of alisertib in small cell lung cancer, including those in combination with paclitaxel, suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib.” Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, “We are pleased to initiate this Phase II trial, and we hope that the study will provide important insight into the safety and clinical activity of alisertib in combination with paclitaxel in patients with small cell lung cancer. We are continuing to advance alisertib monotherapy in the ALISCA ® -Lung1 trial as well, and we view the ALISCA ® -Lung2 trial as additive to the clinical development of alisertib in small cell lung cancer. We look forward to the progress of both the ALISCA ® -Lung1 and ALISCA ® -Lung2 trials, as well as our other ongoing clinical programs, in the months ahead.” About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. In September 2026, Puma initiated ALISCA ® -Lung2, a Phase II clinical trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at . Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Puma’s expectations regarding the development of alisertib and clinical trials involving alisertib. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, any changes in Puma’s product candidates’ regulatory approvals, results from Puma’s clinical trials, any litigation involving Puma, any changes to Puma’s in-licensed intellectual property and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com

Phase 2Drug ApprovalLicense out/inImmunotherapy

100 Deals associated with Alisertib

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KEGG	Wiki	ATC	Drug Bank
D10085	Alisertib	-	DB05220

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral T-cell lymphoma unspecified refractory	Phase 3	United States	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Australia	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Austria	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Belarus	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Belgium	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Brazil	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Bulgaria	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Canada	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Chile	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Czechia	Millennium Pharmaceuticals, Inc.	11 Jun 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06369285 (ALISCA-Breast1, ESMO2026)	Phase 2	Metastatic breast cancer HR+ \| HER2-	225	Alisertib 40 mg	qypacnxyms(qkuxtilxem) = neutropenia, anemia, and leukopenia qechbukxxj (itmjrxpqpv )	Positive	23 Oct 2026
NCT06095505 (PUMA-ALI-4201, WCLC2026)	Phase 2	Small Cell Lung Cancer	50	Alisertib 50 mg BID	qkrjcldssi(yyfyzrtgxg) = yrmbgilqau chindcowia (rmmeczaqni ) View more	Positive	12 Sep 2026
SABCS2025	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER+/HER2-	126	Alisertib monotherapy	hqmejgbjyl(ppomdxfkip) = hematologic AEs (neutropenia, leukopenia, and anemia), and fatigue. bbkwfbrlzd (okeobnqwxe )	Positive	10 Dec 2025
				Alisertib ± fulvestrant
SNO2025	Phase 2	Rhabdoid Tumor of the CNS First line	71	Alisertib + chemotherapy + focal radiotherapy (Stratum B1)	mahcktpdpk(szewqvwzlk) = ajkbtylqrh bssexdzvpi (madyksdidk ) View more	Negative	19 Nov 2025
				Alisertib + chemotherapy + radiotherapy (Stratum B2)	mahcktpdpk(szewqvwzlk) = mjsvscbijk bssexdzvpi (madyksdidk )
NCT06369285 (ALISCA-Breast1, ASCO2025)	Phase 2	Hormone receptor positive HER2 negative breast cancer RB1 \| MYC \| TP53 ... View more	-	Alisertib 30 mg + Endocrine Therapy	mxnvrlmekw(kyssvdwgii) = upwiubzygh dncrwnweth (lrtdcrstkr ) View more	Positive	30 May 2025
				Alisertib 40 mg + Endocrine Therapy	mxnvrlmekw(kyssvdwgii) = wiwflllrwa dncrwnweth (lrtdcrstkr ) View more
NCT04555837 (CTgov)	Phase 1/2	Squamous cell carcinoma of head and neck metastatic \| Squamous Cell Carcinoma of Head and Neck \| Malignant Solid Neoplasm	24	Alisertib+Pembrolizumab (Phase I)	skkjaecvpx = obqlvhafez fgsolmztdv (gfcwximctf, ysoyfxgees - mfzbtywyku) View more	-	16 Dec 2024
				Alisertib+Pembrolizumab (Phase II)	dhlyqdtqzy = kshcdicezw dvpmhwdpfd (feueatyzdj, pgknzgzzoh - klemnaygus) View more
NCT02860000 (TBCRC041 \| MC1431, CTgov)	Phase 2	Locally advanced breast cancer \| Metastatic breast cancer \| Hormone refractory breast cancer ... View more	96	Laboratory Biomarker Analysis+Alisertib (Arm I (Alisertib))	adgslddroi = eytdshkjwq ynndfibfzi (upseeddquj, kcfacthdsq - nyskywlgsb) View more	-	18 Oct 2024
				Laboratory Biomarker Analysis+Alisertib+Fulvestrant (Arm II (Alisertib, Fulvestrant))	adgslddroi = rtwwiczvrd ynndfibfzi (upseeddquj, ppckbqweca - ertrklqbnc) View more
NCT02187991 (CTgov)	Phase 2	Metastatic breast cancer	169	Paclitaxel (ER+/HER2- Paclitaxel Alone)	lxtupbdybu(qxonuucqxo) = qxgfrztvdh vxnzyudias (smryzwzztn, dqfwjdwvhk - upzubqbfbv) View more	-	09 Oct 2024
				Alisertib+Paclitaxel (ER+/HER2- Paclitaxel Plus Alisertib)	lxtupbdybu(qxonuucqxo) = mrniaujijq vxnzyudias (smryzwzztn, rzeappvzwd - nvuwjgbluh) View more
NCT04085315 (phase I/Ib study, ASCO2024) Manual	Phase 1	EGFR Mutation Lung Cancer EGFR	21	alisertib+osimertinib	ddlamajsfq(zicgyvwsmb) = neutropenia (42.9%), anemia (42.9%), and diarrhea (38.1%) gmijokvudy (qbcwvvibfe )	Positive	24 May 2024
NCT02860000 (TBCRC041, ASCO2024)	Phase 2	Metastatic breast cancer ESR1 \| PIK3CAmutation \| AKT1 ... View more	91	Alisertib + Fulvestrant	pjuouhsbfj(whmnozkwek): HR = 1.8 (95% CI, 1.1 - 2.9), P-Value = 0.014	Positive	24 May 2024
				Alisertib

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis