G1 Therapeutics' Breast Cancer Trial Fails; Plans Targeted Job Cuts

G1 Therapeutics, a biotechnology company, announced that its drug Cosela (trilaciclib) did not achieve a statistically significant treatment effect in a Phase III trial for patients with triple-negative breast cancer (TNBC). This outcome has led the company to take various measures aimed at reaching profitability by the latter half of 2025.

The drug Cosela was evaluated in the PRESERVE 2 trial, which assessed its efficacy and safety in TNBC patients prior to undergoing chemotherapy. The trial results indicated no statistically significant benefit for the intent-to-treat population, exhibiting a hazard ratio of 0.91 and a p-value of 0.884. Specifically, the median overall survival for patients receiving Cosela and chemotherapy was 17.4 months, compared to 17.8 months in the control group. Although there was a numerical advantage for Cosela in both PD-L1 positive and negative subgroups, these findings did not reach statistical significance.

Following these results, G1 Therapeutics plans to scrutinize the data further and has noted that no new safety concerns were identified. The company intends to present the trial results at a forthcoming medical conference, although no specific event has been disclosed.

In light of the trial's outcome, G1 Therapeutics has decided to terminate the Phase III PRESERVE 2 trial. The company will also cease hiring new staff and halt investments in a first-line TNBC indication. Additionally, G1 plans to implement a "targeted headcount reduction" to streamline operations, though no exact figures have been mentioned.

These strategic changes are projected to provide G1 Therapeutics with sufficient financial resources to reach profitability by the second half of 2025. Despite these plans, the company's stock price plummeted by more than 50% in premarket trading following the announcement.

Jack Bailey, CEO of G1 Therapeutics, expressed disappointment over the trial results, emphasizing the inherent challenges in developing new treatments for TNBC. He stated that the company did not achieve the anticipated benefits for patients living with this aggressive form of breast cancer.

Moving forward, Bailey indicated that G1 Therapeutics will concentrate on expediting and expanding its business in extensive-stage small cell lung cancer (ES-SCLC). He believes this focus will enable the company to achieve the expected profitability within the next year. G1 Therapeutics is also exploring other myeloprotection applications for Cosela and is actively seeking international partners to broaden the drug's global use.

Cosela received approval from the FDA in 2021 to mitigate the frequency of chemotherapy-induced bone marrow suppression in adults undergoing chemotherapy for ES-SCLC. This marks the company's first commercial product, which is anticipated to generate between $60 million and $70 million in net revenue this year.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!