Biopharmaceutical firm Atara Biotherapeutics has entered into a clinical trial collaboration agreement with Merck to evaluate the combination of its ATA129 with Keytruda (pembrolizumab) for the treatment of patients with nasopharyngeal carcinoma (NPC) associated with Epstein-Barr virus (EBV).
ATA129 is an investigational, allogeneic EBV-specific cytotoxic T-lymphocytes (CTL), while Merck's Keytruda is an anti-programmed death receptor-1 (anti-PD-1) therapy.
The safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ATA129 + Keytruda will be assessed in a Phase I/II trial set to begin next year.
Under the agreement, Atara Bio will sponsor the trial, which will include patients with platinum-resistant or recurrent EBV-associated NPC.
Atara Bio chief scientific officer and research and development executive vice-president Chris Haqq said: “Both ATA129 and Keytruda have shown evidence of objective radiographic responses in NPC, and there is a strong biologic rationale to combine these therapies as their complementary mechanisms of action may enhance the anti-tumour activity."
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ATA129 induces T-cells to identify EBV antigens that are expressed in the cells of some liquid and solid tumours.
The investigational therapy was previously assessed in Phase I and II trials as a monotherapy in patients with various EBV-positive malignancies.
The trial also included 14 patients with chemotherapy refractory, metastatic NPC and showed that EBV-CTLs expanded after treatment and without the associated lympho-depleting chemotherapy.
According to the data from recent studies, EBV upregulates PD-L1 transcription in related solid tumours such as NPC and gastric cancer, which provides scope for combination with anti-PD-1 therapies.