GSK's Blenrep Combinations: A Strategic Oncology Catalyst with Global Market Dominance Potential

The approval of GSK’s Blenrep combinations in Japan on May 19, 2025, marks a landmark moment for the company’s oncology pivot and underscores Blenrep’s potential to redefine treatment paradigms in relapsed/refractory multiple myeloma (RRMM). This $20 billion+ global market is primed for disruption, and Blenrep—backed by robust phase III data—is positioned to capture significant share.

Clinical Validation: Survival and Response Data Signal a New Standard
The DREAMM-7 trial demonstrated Blenrep’s combination with bortezomib/dexamethasone (BVd) nearly tripled median PFS (36.6 vs. 13.4 months) versus standard daratumumab/BVd, while reducing mortality risk by 42% (OS HR 0.58). DREAMM-8 further validated its efficacy in pomalidomide/dexamethasone (PomDex) combinations, with PFS improvement (HR 0.52) and deeper remissions (24-32% MRD negativity vs. 5% in comparators). These data, alongside manageable safety profiles (≤9% treatment discontinuation), establish Blenrep as the first BCMA-targeted ADC with definitive OS benefits in RRMM.

Regulatory Momentum: Japan’s Approval Paves the Way for Global Dominance
Japan’s nod—accelerated via orphan designation—follows the UK’s April 2025 approval and precedes critical 2025 catalysts: the U.S. PDUFA date (July 23, 2025) and EU/China submissions. With RRMM affecting ~7,200 new Japanese patients annually and a five-year survival rate of just 43%, Blenrep’s profile addresses a dire unmet need, bolstering its commercial case.

Commercial Scalability: A $20B+ Market Awaits
GSK’s oncology franchise is underappreciated. Blenrep’s combinations could command premium pricing in first-line settings post-progression, with global adoption amplified by its simplicity (no pre-treatment requirements) and broad eligibility (patients with ≥1 prior therapy). With ~150,000 RRMM patients globally, Blenrep’s addressable market exceeds $2 billion annually by 2027, driving near-term revenue upside and long-term franchise value.

Why Invest Now?
The Japan approval removes execution risk, while the U.S. decision in July 2025—a near-certainty given data strength—will catalyze valuation expansion. GSK’s oncology pipeline, anchored by Blenrep, signals a strategic shift toward high-margin therapies. With shares trading at a 25% discount to peers, this is a rare opportunity to capitalize on a transformative oncology asset before its global rollout.

Conclusion: GSK is at a pivotal inflection point. Blenrep’s clinical and regulatory trajectory positions it to dominate RRMM treatment, unlocking multi-billion-dollar opportunities. Investors ignoring this catalyst risk missing a generational oncology play. Act before the U.S. approval—this is a BUY.