Novocure (NASDAQ:NVCR) shares rose 5% on Thursday after the company disclosed topline findings from the Phase 2 PANOVA-4 clinical trial assessing Tumor Treating Fields (TTFields) therapy administered alongside atezolizumab and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.
The PANOVA-4 study met its primary endpoint, recording a statistically significant improvement in disease control rate (DCR) compared with a historical control. In the cohort receiving TTFields therapy in combination with atezolizumab and gemcitabine/nab-paclitaxel, the disease control rate was 74.4% versus 48% observed in patients treated with gemcitabine/nab-paclitaxel alone in the Phase 3 MPACT trial, which was used as the historical comparator.
The trial enrolled 78 patients who received the combination regimen as first-line therapy for metastatic pancreatic ductal adenocarcinoma. The protocol defined disease control rate as the share of patients who experienced either stable disease lasting at least 16 weeks or a confirmed partial or complete response, as assessed by RECIST v1.1 criteria.
Among the secondary efficacy measures reported, the objective response rate (ORR) was 34.6% and median overall survival for patients treated with the combination was 9.7 months. Median exposure to TTFields therapy in the trial was 25.6 weeks, while the median duration of systemic therapy was six cycles for the atezolizumab plus gemcitabine/nab-paclitaxel regimen.
Novocure said TTFields therapy was well-tolerated in the study population and that device-related safety findings aligned with prior clinical experience. The company indicated it will present additional PANOVA-4 results at a future scientific forum.
Market reaction and context
Shares moved higher on the publication of the topline data. The company intends to provide more detailed analyses at an upcoming scientific meeting, where further information on efficacy and safety may be disclosed.
Key points
- PANOVA-4 met its primary endpoint with a DCR of 74.4% for the TTFields combination versus 48% in the historical MPACT control.
- Secondary results included a 34.6% objective response rate and a median overall survival of 9.7 months for patients on the combination regimen.
- TTFields therapy was described as well-tolerated, with device-related safety consistent with prior studies; Novocure plans to release more data at a scientific forum.
Risks and uncertainties
- The comparative efficacy is reported versus a historical control (Phase 3 MPACT), rather than a contemporaneous randomized control arm; the study design may limit direct comparability.
- Topline results provide an initial view but detailed data and peer-reviewed presentation are pending; additional findings could affect interpretation of the trial outcomes.
- Safety conclusions are preliminary and based on the study cohort; broader safety characterization will depend on fuller data disclosures.