Puma Biotechnology, Inc. PBYI announced that it has initiated the phase II ALISCA-Breast1 study evaluating its pipeline candidate, alisertib, for the treatment of patients with metastatic breast cancer.

The ALISCA-Breast1 study is investigating alisertib in combination with endocrine therapy for treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast cancer in patients who have been previously treated with CDK 4/6 inhibitors and have received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.

The main objective of the ALISCA-Breast1 study is to determine the optimal dose of alisertib in combination with a selected endocrine therapy. Initial data from the study is expected in 2025.

Upon finding the optimal dose of alisertib, PBYI plans to meet with global regulatory agencies for the design of a pivotal phase III study on the candidate. The study will evaluate alisertib plus investigator’s choice endocrine therapy compared with placebo plus investigator’s choice endocrine therapy in HER2-negative, HR+ metastatic breast cancer.

PBYI's Stock Performance

Year to date, shares of Puma Biotechnology have plunged 34.4% compared with the industry’s decline of 10.9%.

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The primary endpoints of the ALISCA-Breast1 study are to check the objective response rate, duration of response, disease control rate, progression-free survival and overall survival.

The company will evaluate each of these efficacy endpoints within biomarker subgroups to find out whether any biomarker subgroup correlates with response as a secondary endpoint.

PBYI then plans to conduct an initial interim analysis for the investigation of the safety and efficacy of the above study.

Based on the outcomes of the ALISCA-Breast1 study, the company plans to meet with the FDA for a potential approval pathway for alisertib in HER2-negative, HR+ metastatic breast cancer.

PBYI's Development of Alisertib Holds Promise

Puma Biotechnology in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022.

Apart from breast cancer, the company is conducting ALISCA-Lung1, a phase II study (PUMA-ALI-4201) evaluating alisertib as a monotherapy for the treatment of patients with extensive stage small cell lung cancer. Interim data from this study is expected to be presented in 2025.

Per management, alisertib has huge potential in HR-positive, HER2-negative breast cancer, triple-negative breast cancer, head and neck cancer and small cell lung cancer. If successfully developed for these indications, alisertib has the potential to boost the company’s position in the anticancer drug market.

PBYI's Zacks Rank & Key Picks

Puma Biotechnology currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.6%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 18.3%.

SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 31.8%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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