IMV Inc. Presents Updated Positive Data From Phase 1b/2 Combination Clinical Trial in Advanced Ovarian Cancer at 2018 ESMO Immuno-Oncology Congress
73% of tumor regressions and 80% of clinical responses were observed in a subpopulation defined by a clinical biomarker based on Baseline Tumor Burden
All durable clinical responses continued beyond the one year of treatment, surpassing the progression-free interval from patients’ previous chemotherapy treatment
New data supports the correlation between DPX-Survivac’s novel T-cell activating mechanism of action and tumor regressions
IMV to hold investor call on
In a poster presentation,
Key findings include:
- Evidence of a clinical marker based on Baseline Tumor Burden (BTB), a measure of tumor size predictive of patient response to DPX-Survivac.
- 37.5% (12/32) of evaluable study subjects began treatment with a non-bulky disease defined as BTB < 5 cm.
- 73% (8/11) of tumor regressions and 80% of clinical responses (4/5) observed in subset of patients with BTB < 5 cm.
- Responders thus far showing prolonged duration of clinical benefits reaching up to more than two years, surpassing the progression-free interval from their previous chemotherapy treatment.
- Robust systemic survivin-specific T cell responses and evidence of survivin-specific T cells tumor infiltration correlated with clinical benefits.
- 100% of durable clinical responses correlated with T cell infiltration.
- Epacadostat triggered inhibition of the conversion of tryptophan into kynurenine that was dose dependent.
- Cohort demographics were balanced and the combination yielded a tolerable safety profile.
“This data set provided meaningful information on how the potential benefits of DPX-Survivac may best be translated to patients, including the connection between tumor regressions and T cell infiltration in the tumor microenvironment,” said
Updated Clinical Response and Safety Data for DeCidE1
At the time of data cut-off, 53 patients were enrolled in the phase 1b clinical trial, including 14 from the 100 mg epacadostat dosing cohort and 39 from 300 mg epacadostat cohort. Based on 300 mg cohort results, IMV and Incyte agreed to stop dosing patients with epacadostat before completion of the study. Patients who completed at least one CT scan, as required per the trial protocol, were evaluable for response analysis.
71% of patients were evaluable for responses in the 100 mg cohort and 56% in the 300 mg dose cohort. At time of data cut-off, 8 participants remained on treatment and were being evaluated for clinical responses.
|Total target lesion size < 5 cm||Total target lesion size > 5 cm|
|Regression||5 (100)||3 (42.9)||8 (66.7)||0 (0)||3 (20.0)||3 (15.0)|
|PR(1)||3 (60.0)||1 (14.3)||4 (33.3)||0 (0)||1 (6.7)||1 (5.0)|
|SD(2)||2 (40.0)||4 (57.1)||6 (50.0)||2 (40.0)||10 (66.7)||12 (60.0)|
|DCR(3)||5 (100)||5 (71.4)||10 (83.3)||2 (40.0)||11 (73.3)||13 (65.0)|
|(1) Partial Response (PR) is defined as ≥30% decrease in sum of target lesions.|
|(2) Stable Disease (SD) is defined as ˂ 30% decrease and ≤ 20% increase in sum of target tumor lesions.|
|(3) Disease Control Rate (DCR) refers to the total number of patients achieving complete response, partial response, and stable disease.|
“Recurrent ovarian cancer treatment remains a significant unmet need and represents a challenge for immunotherapy,” said
|Poster Session Details|
|Session Title:||Poster Display Session|
|Location:||Foyer, Geneva Palexpo|
|Poster ID:||87P; Abstract ID 262|
|“New clinical data from the DeCidE1 trial: Results on DPX-Survivac, low dose cyclophosphamide (CPA), and epacadostat (INCB024360) in subjects with advanced recurrent epithelial ovarian cancer”|
Investor Call Information
IMV will host a webcast and conference call on
- Dial-in: (844) 461-9932 (
U.S.and Canada) or (636) 812-6632 (International)
- Conference ID#: 6192578
- A live audio webcast and presentation will be available via this link, or by pasting this URL in an internet browser: https://edge.media-server.com/m6/p/5uokxhky
About the DeCidE1 Phase 1b/2 Trial
The phase 1b/2 trial is an open label, uncontrolled, safety and efficacy study for individuals with advanced, platinum-sensitive and resistant ovarian cancer. The phase 1b portion has two dosing cohorts:
- 100 mg of epacadostat twice daily (BID), with DPX-Survivac and low dose cyclophosphamide, and
- 300 mg of epacadostat BID in combination with DPX-Survivac and low dose cyclophosphamide.
The primary endpoints are to determine:
- The safety profile of the combination regimen,
- Induction of systemic survivin-specific T cells in the blood, and
- Induction of T cell infiltration into tumors.
Secondary endpoints include objective response rate (ORR) using modified RECIST v1.1 criteria; duration of response based on modified RECIST criteria; time to progression (TTP); and overall survival (OS).
IMV conducted the phase 1b/2 study in collaboration with Incyte Corporation. IMV recently announced that, based on the 300 mg cohort results, IMV and Incyte have agreed to stop dosing patients in this trial with epacadostat. IMV is continuing the phase 2 portion of the trial as a monotherapy study evaluating DPX-Survivac in the advanced and recurrent ovarian cancer subpopulation with BTB < 5 cm.
IMV intends to report updated results from the phase 1b when data from at least 16 evaluable participants in the second dosing cohort are available. Investigators plan to submit final results for publication in a peer-reviewed journal.
About Ovarian Cancer
According to the
Ovarian cancer has a significant impact globally as well.
IMV Forward-Looking Statements
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Source: IMV Inc.