Massarelli E et al., Melief CJ, Glisson B. “Combining Immune Checkpoint Blockade and Tumor-Specific Vaccine for Patients With Incurable Human Papillomavirus 16-Related Cancer: A Phase 2 Clinical Trial” JAMA Oncol. 2018 Sep 27. [Epub ahead of print]
Describes the outcome of an investigator sponsored trial conducted at MD Anderson Cancer Center in patients suffering from advanced HPV16 positive Head and Neck cancer, combining ISA101 with nivolumab. Data demonstrate that the ORR of 36% in patients with oropharyngeal cancer compares favourably to the ORR of 16% demonstrated for nivolumab monotherapy in patients with p16-positive platin-refractory oropharyngeal cancer participating in the in Checkmate 141 study.
Describes the results of the CervISA study. This was an open label, phase 2 study in patients with late stage HPV16 positive cervical cancer. Seventy-seven patients were treated with ISA Pharma’s lead product, ISA101b, an HPV16-specific immunotherapeutic agent, in combination with standard-of-care (SoC) chemotherapy (carboplatin/paclitaxel). The addition of ISA101b to SoC chemotherapy led to a strong and highly specific anti-tumor immune response and significant improvement of patient survival in responding patients .
Welters MJ, van der Sluis TC, van Meir H, et. al., Melief CJ, van der Burg SH. “Vaccination during myeloid cell depletion by cancer chemotherapy fosters robust T cell responses.” Sci Transl Med. 2016 Apr 13;8(334):334ra52
Describes the outcome of the clinical pilot study in cervical cancer, combining ISA101 with chemotherapy.
van Poelgeest MI, et al., Melief CJ, van der Burg SH. “Vaccination against oncoproteins of HPV16 for non-invasive vulvar/vaginal lesions: lesion clearance is related to the strength of the T-cell response.” Clin Cancer Res 2016 Jan 26;22(10):2342-50.
Demonstrates that vaccination with ISA101 induces objective partial or complete histological regression of the lesion in more than 50% of the patients and as such is an effective means to treat VIN that may prevent surgical mutilation.
Describes the mechanism of the synergy of peptide vaccination with cisplatin, which render tumor cells more susceptible to cisplatin-mediated apoptosis.
Describes the proof-of-concept established in our first trial in HPV-16 induced pre-cancerous neoplasia. ISA was the first to demonstrate a correlation between immune responses and clinical responses.