Novartis will flood the 2025 ASH and SABCS meetings with more than 70 data readouts, including 11 oral presentations and a late-breaker for ianalumab in immune thrombocytopenia. Across hematology, the company will showcase pivotal and long-term data spanning ianalumab (VAYHIT2 Phase III in steroid-exposed ITP), asciminib in CML (ASC4FIRST week 96 PRO and tolerability analyses, ASC2ESCALATE efficacy in 1 prior TKI, and a real-world second-line comparison versus ATP-competitive TKIs), pelabresib plus ruxolitinib in myelofibrosis with 96-week follow-up from MANIFEST-2, interim Phase II results of rapcabtagene autoleucel (YTB323) in first-line high-risk LBCL, and multiple long-term and subgroup analyses for oral complement factor B inhibitor iptacopan in PNH. At SABCS, Kisqali takes center stage with a five-year DDFS readout from the adjuvant NATLEE trial, pooled long-term outcomes from MONALEESA, and pragmatic guidance on drug–drug interactions in early and metastatic HR+/HER2− breast cancer.
This is less a congress appearance than a coordinated evidence offensive. Novartis is pressing advantages where classes are crowded and payer scrutiny is high, betting that durability, patient-reported outcomes, and real-world comparators can shift guidelines and access. The strategic question is whether a dense, cross-modality dataset can convert into earlier-line positioning and broader labels before competitors land their own late-phase shots.
The ianalumab late-breaker could be the most disruptive near term. If VAYHIT2 confirms clinically meaningful benefit when added to eltrombopag in steroid-exposed ITP, Novartis could reframe a TPO-RA–dominated, relapse-prone landscape toward immune-modulating, steroid-sparing strategies. That would affect treatment sequencing for hematologists and sharpen payer conversations around remission durability, corticosteroid avoidance, and bleed-related utilization.
In CML, asciminib continues a deliberate move up the treatment stack. Ninety-six–week PRO and tolerability advantages over investigator-selected TKIs, bolstered by real-world second-line data, speak directly to adherence, discontinuation, and dose modification burdens that drive total cost in a market awash with generics and entrenched second-generation TKIs. Commercial teams will need to translate safety and QoL deltas into economic value propositions, while Medical Affairs arms oncologists with practical switching and monitoring playbooks.
For myelofibrosis, 96-week pelabresib data are about more than endurance; they signal whether BET inhibition can deliver additive, disease-modifying benefit on top of ruxolitinib beyond early spleen and symptom control. With momelotinib’s anemia profile reshaping frontline choices, pelabresib’s long follow-up could be pivotal for differentiation. Meanwhile, YTB323’s foray into first-line high-risk LBCL aligns with the broader push to bring CAR-T earlier, but commercial viability will hinge on manufacturing cadence, center throughput, and the ability to meet time-to-treatment expectations that often favor chemoimmunotherapy or bispecifics.
Iptacopan’s long-term datasets reinforce a shift from C5 inhibition to proximal complement blockade in PNH, spotlighting oral monotherapy convenience and hemoglobin normalization across subgroups, including those transitioning from anti-C5s. Expect payers to test step-edits and outcome guarantees, making RWE on transfusion independence and fatigue critical.
At SABCS, the Kisqali agenda is a clear bid to anchor the adjuvant CDK4/6 market. Five-year DDFS across key subgroups, coupled with pragmatic DDI management, is the package community oncologists and payers will scrutinize as they weigh broad adoption in early breast cancer against toxicity, adherence, and budget impact. If risk stratification and duration management are compelling, Kisqali could reshape a vast adjuvant population where prior attempts struggled to show benefit.
The next 12 months will reveal whether Novartis can convert congress momentum into label expansions, guideline upgrades, and payer alignment across franchises. Watch for the speed of regulatory moves in ITP and adjuvant HR+/HER2− disease, the positioning of asciminib earlier in CML, and whether first-line CAR-T in LBCL can scale operationally as rivals advance. The open question: can an evidence-dense strategy outpace class headwinds and deliver durable share gains before the next wave of competitors resets the bar?
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
