At 15.3 months median follow-up:

• 100% MRD negativity (10⁻⁶) across all treated patients

• 100% overall response rate

• ~90% complete or stringent complete responses

• No disease progression or deaths observed

• Deep responses achieved after a single infusion, without induction or bridging therapy

Source: Nature

Now contrast this with phase 3 standards built around Darzalex-based regimens:

• ORR: ~90–93% (MAIA, NDMM setting)

• ≥CR: ~30–50% range depending on backbone

• MRD negativity: typically ~10–32% even in best combinations

• Median PFS: ~5 years in optimal populations

• Continuous multi-drug therapy required to maintain disease control

By the way, the Darzalex/Darzalex Faspro generated $3.96 billion in sales for Johnson & Johnson in Q1, up 22.5% year-over-year.

Source: graph was made by Author based on the financial reports of Johnson & Johnson

The key gap is not response rate — it is depth of response at the molecular level.

Darzalex-based regimens control disease over time.
CAR-T in this dataset is showing something different: potential complete molecular eradication in a pre-symptomatic disease window.

This is why the Dana-Farber HR-SMM dataset matters.

It suggests that when multiple myeloma is treated earlier — before full clonal expansion — CAR-T may not just extend progression-free survival, but fundamentally shift the therapeutic endpoint from chronic control to functional cure signals.

But the structural message is clear:

The gap between ~30% MRD negativity (best-in-class anti-CD38 therapy) and 100% MRD negativity (CAR-T in HR-SMM) is no longer incremental.