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Junshi Biosciences announced their collaboration on a clinical trial program designed to investigate the efficacy and safety of anti-PD-1 mAb toripalimab in combination with Cetuximab as a treatment for recurrent and/or metastatic squamous cell carcinomas of the head and neck in China. Cetuximab is an IgG1 monoclonal antibody that specifically targets the EGFR. The inhibition of EGFR blocks the processes involved in tumor cell growth and progression. Cetuximab is also a potent inducer of antibody-dependent cell mediated cytotoxicity, inducing antitumor immune effect. In February 2020, Cetuximab was granted an approval by China's National Medical Products Administration for the first-line treatment of R/M SCCHN using a combination chemotherapy regimen. Developed by Junshi Biosciences, toripalimab is the first domestically marketed PD-1 monoclonal antibody in China. Anti-PD-1 mAb is an immunotherapy that can activate and direct the body's own immune system to attack tumor cells by inhibiting the PD-1 pathway. Over 30 toripalimab mono and combo clinical trials have been conducted globally for more than 10 tumor types, and show encouraging anti-tumor outcomes. Cetuximab and PD-1 inhibitors are believed to have a synergistic mechanism of action in SCCHN treatment. Preliminary data of early-phase studies have shown promising results from combining immune checkpoint inhibitors with cetuximab.

AstraZeneca (AZN) and Merck (MRK) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending LYNPARZA for approval as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. The CHMP based its positive opinion on results from the Phase 3 POLO trial, which were previously published in The New England Journal of Medicine. The trial demonstrated LYNPARZA nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo.

Immutep (IMMP) has reported first interim data from its ongoing INSIGHT-004 Phase I clinical trial. The study is a phase I trial evaluating the combination of Immutep's lead product candidate, eftilagimod alpha with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers. Avelumab is co-developed and co-commercialized by Merck (MRK) KGaA, Darmstadt, Germany and Pfizer (PFE). The data was reported in a short talk poster presentation at the virtual event for the 2020 American Society of Clinical Oncology's Annual Meeting. INSIGHT-004 is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being conducted under Immutep's collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer, and is evaluating the safety, tolerability and recommended Phase II dose of efti when given in combination with avelumab. Patients in cohort 1 receive 6mg doses of efti every two weeks with the standard dose of avelumab, while patients in cohort 2 receive a higher dose of efti, 30mg, with avelumab. INSIGHT-004 reached full recruitment in April 2020 and has recruited patients in different solid tumors, primarily with gastrointestinal indications. It is the first combination trial of an approved and marketed anti-PD-L1 drug and efti. Salah-Eddin Al-Batran, INSIGHT-004 trial investigator and Director of Oncology at IKF said: "It is good to see a number of patients are responding to the combination therapy of efti and avelumab, particularly as three patients in cohort 2 are still very early on in their treatment and haven't yet been assessed. INSIGHT-004 is progressing well and we are pleased that efti continues to be safe and well tolerated by patients. These patients typically are heavily pretreated and do not have any good therapy options."

Immutep (IMMP) announced new interim data from its ongoing Phase II TACTI-002 study. This data relates to the cut-off date of 4 May 2020 and shows "improving efficacy results," the company said. The results were presented as a poster short talk at the 2020 American Society of Clinical Oncology Virtual Annual Meeting. TACTI-002 is being conducted in collaboration with Merck (MRK). The study is evaluating the combination of the company's lead product candidate eftilagimod alpha with Merck's KEYTRUDA in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma or Non-Small Cell Lung Cancer in first and second line. Immutep CSO and CMO, Frederic Triebel said: "TACTI-002 is generating increasingly promising data from both the NSCLC and HNSCC arms of study, as patients continue to receive efti in combination with KEYTRUDA. Remarkably, one HNSCC patient has even achieved a complete response, bringing the total response rate to an improved 39% in this arm. This is an early indication that the efti in combination with pembrolizumab may more than double the proportion of HNSCC patients that respond to pembrolizumab monotherapy, which is usually 18% or less1."