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Novartis reveals positive Phase 3 data for tislelizumab plus chemotherapy in esophageal cancer

The Swiss Big Pharma Novartis (NYSE:NVS) announced that the anti-PD-1 immune checkpoint inhibitor tislelizumab with chemotherapy improved overall survival in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in a Phase 3 study.

The RATIONALE 306 trial of tislelizumab and chemotherapy met its primary endpoint at interim analysis. The study pitted the combination therapy against chemotherapy as a monotherapy.

Novartis noted that the study focusing on first-line ESCC follows on the heels of FDA and EMA accepting tislelizumab in a second-line context.

The company is optimistic that the drug could treat a variety of solid tumors.

To date, tislelizumab has been the subject of more than 200 clinical studies.

Novartis licensed rights to the drug from BeiGene in February 2021 for $650 million upfront plus another $1.55 billion in potential milestone payments.

The Swiss company noted that it would collab…

Zymeworks to cut headcount at least 25% by end of 2022

Soon after taking the reins of Zymeworks (NYSE:ZYME), new chair and CEO Kenneth Galbraith has decided to sharpen the company’s focus and reduce the firm’s headcount.

To free up cash, the company plans to lay off at least one-quarter of its staff, including 10 members (50%) of its senior management team.

The Vancouver–headquartered company also intends to focus on executing its clinical development programs for the HER2-targeted bispecific antibody zanidatamab and ZW49, a HER2-targeted antibody-drug conjugate.

Ken Galbraith

In December, Zymeworks and its partner BeiGene (NSDQ:BGNE) announced the dosing of the first patient with zanidatamab in a South Korean study.

In the organizational shift, the company also intends to streamline its R&D activities while hunting for new potential partnerships and collaborations.

“Upon assuming my new role effective January 15th, we have moved …

Zymeworks and its partner BeiGene expand zanidatamab pivotal trial in Asia

Zymeworks (NYSE:ZYME) and its collaborator BeiGene have announced the dosing of the first patient with zanidatamab (ZW25) in South Korea–based HERIZON-GEA-01 study. The study will focus on patients with advanced or metastatic HER2-positive gastroesophageal adenocarcinomas.

As a result of the development, Zymeworks will receive an $8 million development milestone payment from BeiGene.

Zymeworks and BeiGene plan to open roughly 300 clinical trial sites in 38 countries for the global HERIZON-GEA-01 pivotal trial. The companies anticipate approximately 700 patients to enroll in the study.

The Phase 3 trial will evaluate zanidatamab with a physician’s choice of chemotherapy (capecitabine/oxaliplatin or 5FU/cisplatin) with or without the PD-1 inhibitor tislelizumab. The study will pit that cohort against a group receiving trastuzumab and a physician’s choice chemotherapy.

Zanidatamab, a bispecific antibody, is one of Zymeworks’ lead drug candidates.

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