Top Stories
BMS Wins Dual US and EU Approvals for Opdivo in Classical Hodgkin Lymphoma
Bristol Myers Squibb secured two landmark approvals for Opdivo (nivolumab) in classical Hodgkin lymphoma on March 20, 2026. The US FDA approved Opdivo in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adults and pediatric patients aged 12 and older with previously untreated Stage III or IV cHL — the first immunotherapy-based regimen approved in the frontline advanced setting. Separately, the European Commission approved Opdivo in combination with brentuximab vedotin for children aged five and above, adolescents, and adults up to 30 years with relapsed or refractory cHL after one prior line of treatment. The US approval is based on the Phase 3 SWOG S1826 trial of 994 patients, which showed Opdivo-AVD reduced the risk of progression or death by 58% versus brentuximab vedotin-AVD (HR 0.48; one-year PFS 94% vs 86%). Three-year follow-up confirmed durable benefit with PFS of 89% versus 80% in Stage IV patients. The EU approval is based on the Phase 2 CheckMate-744 trial in children, adolescents, and young adults with R/R cHL. Per BMS's 2024 annual report, Opdivo generated $9.3 billion in 2024 worldwide sales. BMS establishes Opdivo as a new frontline standard in advanced cHL, displacing Seagen/Pfizer's Adcetris-AVD combination. Pfizer's Adcetris (brentuximab vedotin) loses frontline cHL positioning after serving as the comparator arm in SWOG S1826.
Karyopharm Posts Mixed Phase 3 Results in Myelofibrosis
Karyopharm reported mixed results from its Phase 3 trial testing selinexor (Xpovio) plus Jakafi in first-line myelofibrosis patients, according to Endpoints News and Fierce Pharma. The combination achieved one co-primary endpoint but failed on the other, creating regulatory uncertainty for the struggling biotech. Selinexor plus Jakafi demonstrated statistical significance for Total Symptom Score reduction but missed on spleen volume reduction compared to Jakafi alone. The mixed results complicate Karyopharm's expansion strategy for Xpovio, approved under the FDA's accelerated approval pathway in relapsed multiple myeloma with limited commercial success. Fierce Pharma reported that Karyopharm will meet with FDA to discuss potential approval pathways despite the mixed efficacy profile. The company desperately needs new indications to revive Xpovio sales, which per Karyopharm's financial disclosures peaked at $102 million annually. Incyte Jakafi maintains first-line monopoly position Karyopharm faces continued Xpovio commercial struggles
Chinese CML Trial Launches as TKI Competition Intensifies
Shenzhen TargetRx initiated a Phase 3 trial for TGRX-678 in chronic myelogenous leukemia patients in China, according to ClinicalTrials.gov data. The trial targets the crowded TKI market dominated by Novartis Gleevec, Bristol Myers Sprycel, and Pfizer's Bosulif. TGRX-678 represents the latest attempt by Chinese biotechs to capture domestic CML market share through local development programs. Per industry estimates, the CML TKI market in China exceeds $400 million annually, driven by increasing diagnosis rates and improved healthcare access. Chinese regulatory authorities have fast-tracked several domestic TKI programs to reduce dependence on Western pharmaceuticals. TargetRx has not disclosed TGRX-678's differentiation strategy versus established TKIs, though resistance profile and safety could provide competitive advantages. The trial launch follows similar Chinese CML programs from BeiGene and Hutchmed. Chinese patients gaining access to domestic TKI options Western TKI franchises facing pricing pressure from local competition
Pipeline Watch
Sucharu Prakash from Texas Oncology highlighted the Pathologic Response Evaluation and Detection in Circulating Tumor-DNA Study, according to OncoDaily. The research focuses on improving ctDNA-based monitoring for treatment response assessment across multiple cancer types. This aligns with growing industry focus on liquid biopsy integration into routine oncology practice.
Competitive Landscape
BMS's dual US and EU approvals position Opdivo-AVD as the new frontline standard in advanced cHL based on SWOG S1826, per European Pharmaceutical Review and Business Wire. BMS captures frontline cHL share from Adcetris-AVD with superior PFS data (HR 0.48). Pfizer/Seagen's Adcetris loses first-line advanced cHL positioning after serving as inferior comparator.
| Regimen | Company | Trial | 1-Yr PFS |
|---|---|---|---|
| Opdivo-AVD | BMS | SWOG S1826 | 94% |
| Adcetris-AVD | Pfizer | SWOG S1826 | 86% |
Karyopharm's mixed Phase 3 data preserves Incyte Jakafi's first-line monopoly, according to Endpoints News and Fierce Pharma reporting. Incyte maintains 80% myelofibrosis market share Karyopharm Xpovio expansion plans stalled
TGRX-678 Phase 3 launch represents growing Chinese challenge to Western CML franchises, per ClinicalTrials.gov data. Local development programs target $400 million annual domestic market through pricing advantages and regulatory fast-tracking.
Forward Looking
- Watch for BMS Opdivo-AVD uptake in frontline advanced cHL through H2 2026 as oncologists shift from Adcetris-AVD. Three-year SWOG S1826 follow-up data and real-world safety comparisons will drive guideline updates and payer coverage decisions.
- Karyopharm FDA meeting timing critical for Xpovio myelofibrosis approval path given mixed Phase 3 endpoints and commercial pressures.
- Chinese TKI programs from TargetRx, BeiGene may force Western pricing concessions in Asia-Pacific CML markets through 2026-2027.
- ctDNA response monitoring adoption accelerating as Texas Oncology and academic centers validate liquid biopsy clinical utility across cancer types.