17:00 Mon 02 Jun 2014
Scancell Hlds - Update on Phase 1/2 trial of SCIB1 in melanoma
Update on Phase 1/2 clinical trial of SCIB1 in Stage III/IV melanoma
Further evidence of tumour reduction and disease control, enhanced immune responses and highly encouraging survival times
The Phase 1/2 trial is an open label, non-randomised study to determine the safety and tolerability of four dose levels of SCIB1 administered intramuscularly using an electroporation device. While the primary objective of the study is to access safety and tolerability, the secondary objectives are to evaluate cellular immune responses and to assess any tumour response.
Highlights
· SCIB1 is safe and well-tolerated, with no dose-limiting or grade 4/5 toxicities observed
· Five of 11 patients in Part 1 receiving 2, 4 or 8mg doses have shown evidence of a clinical response
· Part 1 patients receiving 2mg/4mg doses of SCIB1 had 1-year and 2-year survival rates of 100% and 67%, respectively
· All five Part 1 patients receiving 8mg doses of SCIB1 remain alive
· All 14 Part 2 patients with resected tumours are still alive 16-24 months after study entry (median 21 months); only three patients have disease progression
· 24 of 28 (86%) evaluable patients developed melanoma-specific immune responses
· Survival times are highly encouraging; only 2 of 25 patients receiving at least three doses of 2-8mg of SCIB1 have died since the study started in 2010
· Eight patients are currently on long term treatment with SCIB1
Prof
Prof Poulam Patel, Chief Investigator for the trial and Professor of Clinical Oncology at the
Part 1 higher dose 8mg study interim results (Stage IV disease only)
· All five patients with Stage IV disease remain alive with a median survival time of 11 months from study entry (range 8-12 months)
· One patient in this cohort has shown a pronounced reduction in lung metastases following SCIB1 treatment, meeting the RECIST* criteria for a partial response by Week 9 of treatment and has started continuation treatment. This is the second patient in the study to show an objective clinical response
· A further patient with breast and lung lesions at study entry remained stable for 6 months and is continuing treatment with SCIB1
· Four of the five patients produced an immune response to SCIB1
· Immune responses to the 8mg dose, measured by Elispot, were up to 10-fold higher than those seen in the lower dose 4mg group; high frequencies of melanoma-specific T cells exceeding 2% of total blood lymphocytes were observed
Part 1 lower dose 2mg/4mg study update (Stage III/IV disease)
· The four patients (of six) who were alive at the time of the
· One patient had multiple tumour lesions which disappeared or decreased in size except for one lesion which was resected; the patient, who is still alive, has subsequently developed another lesion which was also resected
· Two further patients have remained disease-free for 18 and 35 months respectively, having required regular treatment and resection of metastases prior to SCIB1 treatment
· Median survival time in Part 1 patients who received at least three treatments with the 2mg/4mg doses of SCIB1 is now 30 months from study entry and 49 months since diagnosis of metastatic disease
· Five of six patients receiving 2mg/4mg doses of SCIB1 produced an immune response
Part 2 study update (Stage III/IV patients with resected tumours)
· All 14 study patients produced an immune response to SCIB1 treatment
· All patients are still alive after being on the study for between 16 and 24 months
· Only three patients have any evidence of disease progression after 4, 14 and 18 months on the study
· Median survival time of all Part 2 patients since initiating treatment is currently 21 months and 26 months since diagnosis of metastatic disease
Overall survival
Based on clinical staging according to the
· Two M1c patients treated with 0.4mg of SCIB1 had rapidly progressing disease and died after 7 months on study - as expected for patients with visceral metastatic disease. The two other M1c patients received at least 4mg doses of SCIB1; one patient died after 13 months and the other is still alive 11 months after study entry
· The single M1a patient received 2mg/4mg doses and is still alive 38 months after study entry. One M1b patient treated with 0.4 mg of SCIB1 died 16 months after study entry. Of the other five M1b patients, one received 4 mg doses and four received 8 mg doses: they all remain alive. The current median survival time for the M1b patients is 12 months from study entry (range 8-28 months)
· Sixteen patients with fully-resected metastatic disease received either 2mg or 4mg doses of SCIB1 and all remain alive with a current median survival of 22 months (range 16-35) from trial entry. The nine Stage III patients have survived for a median of 26 months since their last resection prior to study entry and two patients have experienced a recurrence (22%). The seven Stage IV patients have survived for a median time of 24 months since their last resection prior to study entry, with two patients showing evidence of disease progression 18 and 20 months post-surgery; this compares extremely favourably with a
Safety
· SCIB1 therapy was well tolerated in all patient groups with no reports of serious drug-related side effects
In conclusion, while this is a Phase 1/2 clinical study and patient numbers are relatively small, there is consistent evidence emerging from this trial that
* RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments.
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Overview of the Phase 1/2 trial design
Part 1 of this single arm, open label, Phase 1/2 clinical trial, conducted in five
In Part 2 of the study, 14 patients with resected Stage III/IV melanoma (nine with Stage III and five with Stage IV) entered the study. One patient was only able to tolerate three doses of 2mg and withdrew from the study. Of the remaining patients, 12 received a full 4mg dose of SCIB1 on five occasions over a period of 6 months and one received four doses of 4mg and one dose of 2mg. In the absence of any serious toxicity in the Part 1 8mg cohort, approval was also obtained to further expand Part 2 to dose up to 13 additional patients with 8mg. Recruitment and dosing of these patients is currently on-going.
During the course of the study, regulatory approval was also granted to continue treating eligible patients for a period of up to 5 years from the formal end of the study. During this period patients can receive further doses of SCIB1 every 3-6 months. Two patients in Part 1 (8mg) and six patients in Part 2 (4mg) are currently receiving extended SCIB1 treatment.
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