MorphoSys (ETR:MOR) has released an early look at data from a Phase I/IIa trial of MOR202, the multiple myeloma drug that Celgene ($CELG) abandoned in March. While the results are free from major red flags, the publication of Phase II data on Genmab (CPH:GEN) and Johnson & Johnson's ($JNJ) rival anti-CD38 drug just days earlier showed the scale of the task now facing MorphoSys.
|MorphoSys CEO Simon Moroney|
Data on both drugs were presented at ASCO. Genmab and J&J went first, delivering the data that have given them the confidence to pitch for a quick approval of daratumumab. The anti-CD38 drug achieved an overall response rate of 29% in heavily pretreated multiple myeloma patients, data that compare favorably to those Onyx used to win approval for Kyprolis in 2012. Daratumumab is now positioned to establish a significant head start over MOR202 and Sanofi's ($SNY) SAR650984 in the anti-CD38 market and has set the efficacy bar fairly high.
Martinsried, Germany-based MorphoSys is hoping the sector plays out like the rheumatoid arthritis market for TNF-blocking antibodies, in which AbbVie's ($ABBV) Humira arrived later than its rivals but cleaned up nonetheless. The Phase I/IIa data presented by MorphoSys at ASCO are too limited and early to underpin conclusions about the likelihood of MOR202 pulling off a similar coup, but they are free from the major red flags some people feared were behind Celgene's decision to drop the drug.
The most severe side effect was a grade 3 infusion reaction. And MorphoSys reported that three of the 42 participants stopped treatment because of adverse events thought to be related to MOR202. Beyond these negatives, MorphoSys found reason for encouragement. The trial has yet to hit the maximum tolerated dose, suggesting it may be possible to ramp up dosing to one 16 mg/kg infusion per week. To date, a biweekly cohort has received 16 mg/kg doses and a weekly group has taken 8 mg/kg infusions. One patient had a very good partial response on 4 mg/kg a week.
If MorphoSys is to fulfill its ambitions for MOR202 to be best in class, later trials must replicate such successes while also furthering peripheral benefits it thinks the drug has over daratumumab. The infusion times of the drugs are one possible selling point of MOR202, which was administered over two hours in the Phase I/IIa trial. Initial infusions of daratumumab take much longer, with the protocol of its Phase I/II trial putting the time at 8 hours. Later infusions take less time, though, and work is underway to cut the initial delivery to 5 hours.
Many are skeptical about whether such benefits will be enough for MOR202 to claw back lost ground on daratumumab. "We still believe the competitive threat [of MOR202 to daratumumab] is limited, particularly given Genmab/JNJ may be at least 18-months ahead," Jefferies analyst Peter Welford wrote in a note to investors.
- read the release
- here's the abstract (PDF)
- and FierceBiotech's daratumumab coverage