Business Context and Reporting Period
This Form 6-K filing by GSK plc, dated November 7, 2022, reports on the results of the DREAMM-3 Phase III clinical trial for Blenrep (belantamab mafodotin). The trial evaluated the drug as a monotherapy versus pomalidomide plus low-dose dexamethasone (PomDex) in patients with relapsed or refractory multiple myeloma (RRMM).
Key Financial Metrics
The filing text does not provide specific financial metrics such as revenue, profit, cash flow, margins, debt, or liquidity. This document is a clinical trial update rather than a financial earnings report.
Material Changes and Trial Results
- Primary Endpoint: The trial did not meet its primary endpoint of progression-free survival (PFS). The hazard ratio (HR) was 1.03 (95% CI: 0.72–1.47).
- Median PFS: Observed median PFS was 11.2 months for belantamab mafodotin versus 7 months for PomDex.
- Response Rates: Overall response rate (ORR) was 41% for belantamab mafodotin compared to 36% for PomDex. Belantamab mafodotin demonstrated a deeper response rate (25% VGPR or better) versus 8% for PomDex.
- Duration of Response (DOR): Median DOR was not reached for belantamab mafodotin versus 8.5 months for PomDex. DOR rates at 12 months were 76.8% and 48.4%, respectively.
- Overall Survival (OS): At the time of analysis, OS data was 37.5% mature. Median OS was 21.2 months for belantamab mafodotin and 21.1 months for PomDex (HR 1.14).
- Safety: The safety profile was consistent with known data, with no new safety signals identified. Grade 3 keratopathy rates were consistent with prior reports.
Guidance, Outlook, and Risks
Regulatory Status: Blenrep holds accelerated FDA approval based on DREAMM-2 results, contingent on confirmation of clinical benefit from a randomized Phase III trial. Data from DREAMM-3 is being shared with health authorities, and discussions are ongoing.
Future Trials: GSK will continue the DREAMM clinical trial program, focusing on combination therapies and dosing optimization to maintain efficacy while reducing corneal events. Data from DREAMM-7 and DREAMM-8 Phase III trials are anticipated in the first half of 2023.
Risks: The filing includes a cautionary statement regarding forward-looking statements, noting risks such as those described in the 2021 Form 20-F, Q3 2022 results, and potential impacts of the COVID-19 pandemic.
Key Facts for Investor Verification
- Confirm the outcome of discussions with health authorities regarding the accelerated approval of Blenrep following the DREAMM-3 primary endpoint miss.
- Monitor the anticipated data release for DREAMM-7 and DREAMM-8 trials in the first half of 2023.
- Review the impact of the DREAMM-3 results on GSK's oncology pipeline valuation and potential regulatory actions in the US and other jurisdictions.
- Verify the safety profile consistency, specifically regarding keratopathy, in the context of ongoing dosing optimization efforts.