Alisertib

Er-Kim and Puma Biotechnology Partner to Bring NERLYNX to Eastern Europe and Central Asia for HER2-Positive Breast Cancer Patients

23 days ago

• Er-Kim has signed an exclusive distribution agreement with Puma Biotechnology to commercialize NERLYNX (neratinib) in ten countries across Eastern Europe and Central Asia, expanding access to this targeted HER2 therapy. • NERLYNX is approved for early-stage HER2-positive breast cancer patients previously treated with trastuzumab-based therapy, as well as for metastatic HER2-positive breast cancer in combination with capecitabine. • The partnership addresses significant regional disparities in breast cancer treatment availability, with breast cancer being the most common cancer among women globally, affecting 2.3 million new patients in 2022.

Puma Biotechnology Advances Clinical Development of Alisertib in Lung and Breast Cancer

3 months ago

• Puma Biotechnology has launched two Phase II clinical trials for alisertib, targeting extensive-stage small cell lung cancer as monotherapy and HER2-negative HR-positive metastatic breast cancer in combination with endocrine therapy. • The company's expansion into alisertib development follows their success with NERLYNX (neratinib), which is FDA-approved for HER2-positive breast cancer in both early-stage and metastatic settings. • Alisertib, an oral aurora kinase A inhibitor, represents Puma's strategic expansion in oncology, with the company securing exclusive development and commercialization rights in September 2022.

Puma Biotechnology Acquires Takeda's Aurora Kinase Inhibitor Alisertib for $7M Upfront

3 months ago

• Puma Biotechnology has acquired rights to alisertib from Takeda for $7 million upfront, with potential milestone payments of $287 million plus royalties. • The aurora kinase A inhibitor will be developed for multiple cancer indications, including hormone receptor-positive breast cancer, triple-negative breast cancer, and small cell lung cancer. • Despite previous setbacks in lymphoma trials, alisertib has shown promising anti-tumor activity both as monotherapy and in combination with other anticancer drugs.

Predictive Oncology's AI Platform Accelerates Cancer Drug Discovery, Outperforming Standard Treatment

3 months ago

• Predictive Oncology's AI platform successfully identified promising cancer drug candidates in just eight weeks, potentially saving 18 months of traditional laboratory testing time. • The AI system made 964 confident predictions from only 92 laboratory experiments on patient tumor samples, achieving 79% coverage of possible experimental combinations. • Two identified drug candidates demonstrated superior performance compared to standard colon cancer treatment, marking a significant advancement in AI-driven drug repurposing.

Puma Biotechnology Reports Strong Financial Performance for Q4 and Full Year 2024

3 months ago

• Puma Biotechnology reported Q4 2024 net income of $19.3 million ($0.39 per share), a significant increase from $12.3 million in Q4 2023, driven by strong NERLYNX sales and a $7.1 million tax benefit. • The company achieved full-year 2024 net income of $30.3 million ($0.62 per share), marking its third consecutive year of profitability while maintaining a strong cash position of approximately $101 million. • Puma advanced its clinical pipeline with the initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer.

Neratinib (NERLYNX®) Included in NCCN Guidelines for HER2-Mutated Cervical Cancer

5 months ago

• Neratinib monotherapy has been added to the NCCN guidelines as a second-line or subsequent therapy for recurrent or metastatic cervical cancer with HER2 mutations. • The inclusion is based on Phase II SUMMIT trial results, which demonstrated neratinib's efficacy in HER2-mutated cervical cancers lacking curative treatment options. • The NCCN designated neratinib as a Category 2A preference, indicating its usefulness in specific circumstances for treating HER2-mutated tumors. • This update aims to increase awareness among physicians and improve treatment decisions for patients with advanced cervical cancer and HER2 mutations.

Tempus Presents New Breast Cancer Research at SABCS 2024, Highlighting AI-Driven Precision Medicine

5 months ago

• Tempus presented research at SABCS 2024, showcasing the use of real-world data and AI to improve outcomes for breast cancer patients. • AURKA amplification was identified as a potential marker of resistance to CDK4/6 inhibitors in HR+/HER2- metastatic breast cancer, impacting progression-free survival. • Metaplastic breast cancer exhibits a distinct molecular phenotype with higher PD-L1 expression, offering insights for new biomarker-selected treatment strategies. • Concurrent tissue and ctDNA testing enhances the identification of actionable variants, reducing the need for repeat biopsies and improving diagnostic yield.

Puma Biotechnology Initiates Phase II Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer

6 months ago

• Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib in combination with endocrine therapy for HR+/HER2- metastatic breast cancer. • The trial will enroll up to 150 patients previously treated with CDK 4/6 inhibitors and at least two prior lines of endocrine therapy, randomized to different alisertib doses. • The primary objective is to determine the optimal alisertib dose, with endpoints including objective response rate, duration of response, and progression-free survival. • Puma plans to analyze biomarker subgroups to identify correlations with response and intends to explore a potential approval pathway with the FDA based on trial outcomes.

Veru Initiates Phase 2 Trial of Enobosarm Plus Abemaciclib in AR+ ER+ HER2- Metastatic Breast Cancer

6 months ago

• Veru Inc. has commenced a Phase 2 clinical trial evaluating the combination of enobosarm and abemaciclib for AR+ ER+ HER2- metastatic breast cancer. • The trial aims to assess the efficacy and safety of the combination therapy in patients who have progressed on prior endocrine therapy and CDK4/6 inhibitors. • Enobosarm, a selective androgen receptor modulator (SARM), is being investigated for its potential to enhance the effectiveness of abemaciclib in this specific breast cancer subtype. • The study targets a patient population with androgen receptor-positive, estrogen receptor-positive, and HER2-negative metastatic breast cancer, addressing a significant unmet need.

Puma Biotechnology Initiates Phase 2 Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer

6 months ago

• Puma Biotechnology has started the ALISCA-Breast1, a Phase 2 clinical trial, to evaluate alisertib plus endocrine therapy for HR-positive, HER2-negative metastatic breast cancer. • The trial aims to determine the optimal dose of alisertib in combination with endocrine therapy, assessing objective response rate, duration of response, and progression-free survival. • Approximately 150 patients who have previously received CDK4/6 inhibitors and at least two lines of endocrine therapy will be enrolled and randomized into three alisertib dosage groups. • Initial data from the ALISCATM-Breast1 trial is expected in 2025, with plans for a Phase 3 study contingent on defining the optimal dose and discussions with the FDA.

Puma Biotechnology Launches Phase II Trial of Alisertib for HR-Positive Metastatic Breast Cancer

7 months ago

• Puma Biotechnology has initiated ALISCA™-Breast1, a Phase II clinical trial evaluating alisertib in combination with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer patients. • The company is expanding its alisertib development program, which began with ALISCA™-Lung1 in February 2024 for extensive-stage small cell lung cancer as monotherapy. • Alisertib, an oral aurora kinase A inhibitor acquired by Puma in 2022, represents the company's strategic expansion beyond its FDA-approved NERLYNX® (neratinib) franchise for HER2-positive breast cancer.

Drug Development Updates