Encouraging results from KAEL-GemVax GV1001 Phase II trial on NSCLC

KAEL-GemVax, a leading oncology biopharmaceutical company, today announced that results from a Phase II trial (CTN-2006) in Stage III non-small cell lung cancer (NSCLC) patients vaccinated with the telomerase peptide GV1001 after chemoradiotherapy and an 8-year update from a phase I/II trial have been published in the November issue of Clinical Cancer, the journal of the American Association for Cancer Research. The study reports that that vaccination with GV1001 is well tolerated, immunizing the majority of NSCLC patients and establishing durable T-cell memory. The authors conclude that the survival advantage observed for immune responders warrants a randomised trial.

Lung cancer remains the leading cause of cancer death in both men and women worldwide, with NSCLC accounting for approx 80% of cases. Lung cancer has one of the lowest survival outcomes of any cancer because over two-thirds of patients are diagnosed at a late stage (III or IV) when curative treatment is not possible. With the need for new treatment strategies, the development of vaccines for NSCLC has received attention more recently, with an increasing interest in combining cancer vaccines with conventional therapy, and this study reports also on an 8-year update on the first GV1001 NSCLC trial, the phase I/II study CTN-2000.

The primary objective of the phase II trial was immunologic response, with toxicity and time to progress as secondary objectives. Twenty three subjects (20 evaluable per protocol) with inoperable stage IIIA/B NSCLC were enrolled at three different centres in Norway. The study population received radiotherapy (2 Gy x30) and weekly docetaxel (20 mg/m²), followed by GV1001 vaccination. Subjects with metastatic disease were excluded. The dosage of GV1001 was based on data from previous dose-escalation trials in NSCLC and pancreatic cancer. The chemoradiotherapy represented institutional standard treatment in 2006 for inoperable stage III NSCLC. The study's decision to include 20 evaluable patients was based on the main study objectives; to show that combined treatment with chemoradiotherapy and GV1001 is feasible and may yield immunization, to provide safety data and to obtain an estimate for PFS and immune response rate. The first GV1001 trial, CTN-2000, evaluated vaccination of 26 advanced NSCLC patients (mostly stage IV) without concomitant chemo- or radiotherapy. Immune responses were detected against GV1001 in 11 out of 24 evaluable patients during the primary regimen and an additional 2 patients following booster vaccines (54%).

The two studies included 49 patients with no treatment related serious adverse effects observed. The phase II study demonstrated an 80% immune response rate per protocol which is high compared with most cancer vaccine trials, including those investigating telomerase-based approaches. Immune responders recorded a median PFS of 371 days, compared with 182 days for non-responders.

The authors found the high immunologic response rate indicated that the vaccine may be useful for the general patient population without prior HLA typing. Moreover, long-term T-cell memory against telomerase antigens was induced without compromising bone marrow function. The particular high immune response rate and low toxicity observed in the phase II trial support the concept of combining vaccination with chemo- or radiotherapy, which is of particular interest for the multimodal clinical development of both GV1001 and other cancer vaccines. The phase I/II trial update further showed a strong correlation between immune response and survival. Taken together, the findings were a strong indication for a larger randomized GV1001 trial in NSCLC patients.

KAEL-GemVax's President, Michelle Kim, welcomed this latest study: "The availability now of long-term data and the association between immune response to GV1001 in NSCLC and clinical outcome is of especial interest to us and we are analysing the data to consider how best to progress these findings to the next stage." KAEL-GemVax, together with Quintiles Limited, will begin a multicenter multinational clinical trial [U.S. Russia, Italy, Norway, Sweden, Poland, Hungary and Korea] for the use of GV1001 in NSCLC. Recruitment will begin in Q1 of 2012 and is expected to reach more than 600 patients.

Source: KAEL-GemVax