ImmunoMedics (IMMU) is gearing up to report updated phase 2 data for its drug IMMU-132 in patients being treated with metastatic triple-negative breast cancer ((mTNBC)). One thing to keep in mind is that this company is seeking FDA approval of IMMU-132 as a third-line therapy treatment for mTNBC. It is my belief that the updated data should be closely similar to previously released data from a smaller cohort (group of patients). Why is this updated presentation important? That's because the updated phase 2 data is what will be included in the Biologics License Application for when ImmunoMedics files for accelerated approval to the FDA in Q1 2018.
Early Phase 2 Data
The BLA package submission will include the new updated phase 2 data. But I wanted to show you a glimpse of prior data that was first revealed, and why I believe that ImmunoMedics has a good shot at receiving accelerated approval for IMMU-132. Accelerated approval has been given to this drug, and could potentially allow for the company to be on the market much earlier than expected. In my opinion, that should boost the stock higher. The small cohort trial was done by recruiting 69 mTNBC patients who had failed at least two other prior therapies (they were heavily pre treated). One thing to note was that this was a single-arm study, but it met the FDA's expectation for accelerated approval for a TNBC drug. It was shown that when a radiological assessment was performed on patients, there was a 30% objective response rate observed. That is over the threshold needed for the FDA to give accelerated approval of IMMU-132. The complete breakdown is that the drug was able to obtain two complete responses and 19 partial responses. The median overall-survival (OS) rate was 16.6 months, and the progression-free survival rate was six months. This phase 2 data is what opened the door for ImmunoMedics to be able to file for accelerated approval in the upcoming first quarter of 2018. Although IMMU-132 was given breakthrough therapy designation after it had revealed this phase 2 data to the FDA.
