Immunomedics Tanks On CRL But Should Recover As No New Studies Are Needed
Terry Chrisomalis
Summary
Immunomedics announced that it received a complete response letter from the FDA for its drug sacituzumab to treat patients with TNBC, causing the stock to tank.
The FDA noted that the complete response letter was only because of CMC portion of the application and Immunomedics won't need to run another study to eventually refile its BLA.
Sacituzumab was attempting to gain FDA approval based on the accelerated approval program, which means it had only completed up to a phase 2 study in treating patients with mTNBC.
The phase 2 study showed that patients treated with sacituzumab had an overall survival rate of 16.6 months and progression-free survival rate of 6 months.
Immunomedics has $585.5 million in cash as of September 30, 2018 which is enough to fund its operations until 2021.
Recently, Immunomedics ( IMMU) announced that it had received a CRL for its breast cancer drug sacituzumab. Specifically, the FDA was reviewing the BLA for this drug to be approved to treat patients with metastatic triple-negative breast cancer (mTNBC) that had received at least 2 prior therapies. This approval is a setback for the biotech, but it should recover easily in the long term. That's because the fixes noted in the CRL can be done quite easily. That's why I think the company will easily bounce back from this issue.
Accelerated ApprovalImmunomedics received a Complete Response Letter (CRL) from the FDA for its BLA of sacituzumab for this breast cancer population. I believe that this biotech will be able to easily handle the CRL because of the problem that was noted. The FDA stated that there was an issue with the Chemistry, Manufacturing, and Control matters in the application. In other words, Immunomedics must now confer with the FDA in a meeting to determine the steps necessary to fix these issues and then on the timeline on when it could potentially refile for approval of this drug. The good news out of the CRL is that the drug was not rejected based on clinical trial data at all. That means no new studies will be necessary in order to eventually resubmit the BLA for approval of sacituzumab. This was a huge blow for the patients who desperately need a new treatment option for mTNBC.
Phase 2 DataThe FDA granted accelerated approval for sacituzumab because of positive data from the latest study. Sacituzumab govitecan (IMMU-132), had already posted positive data in a phase 2 trial in patients with metastatic TNBC. The phase 2 trial was a single-arm study. What that means is that patients were only treated with sacituzumab and then evaluated for Progression-free survival (PFS) and overall-survival (OS). There was no placebo in the trial to be compared to. The overall survival rate was 16.6 months and there was a progression-free survival rate of 6 months. What's important to note here is that this drug works for TNBC patients. These were patients that were already treated with five other prior therapies. That's a lot of therapies to be treated with and see no success. Some of these therapies are: cisplatin, capecitabine, nab-paclitaxel, and eribulin just to name a few. The problem is that these standard of care agents only provide 3.5 months of progression-free survival. Finally, at least 30% of the 69 patients recruited into the trial had an ORR. The breakdown is 2 complete responses and 19 partial responses.
FinancialsAccording to the 10-Q SEC filing, Immunomedics had cash, cash equivalents and marketable securities of $585.5 million in cash as of September 30, 2018. The biotech believes it has enough cash on hand to fund its operations until 2021. Had it obtained approval for for the breast cancer drug, it would have had additional cash runway. That means it will likely have to raise cash by mid-2020. That's the bad news, the good news is that the delay for approval doesn't deal with any type of clinical data. That means no new studies will be necessary. In addition, it notes in its SEC filing that it may seek a partnership for products in the pipeline. If it can achieve that, then it's possible it could avoid a cash raise before then.
ConclusionThere is no question that a CRL for sacituzumab hurt Immunomedics in the short term; however, when looking at the long-term aspect, the drug should be approved within at least a 1-year period. The FDA only noted an issue with the CMC portion of the BLA application. What that means is that the clinical trial data is sound and no new studies will be needed in order to refile a BLA. That's not to say that there is no risk involved. The CMC portion of the application will need to be fixed and that still remains a partial risk. Before anything can happen, though, Immunomedics will need to hold a meeting with the FDA to determine exactly what is needed to fix the CMC in order to eventually receive approval of sacituzumab for TNBC. The risk I see for now is the amount of time it will take to meet with the FDA and then additional time to flesh out the CMC portion of the application. Other than that, there is no safety risk or efficacy problem noted with sacituzumab and that is very good news. I believe Immunomedics will recover just fine if it can fix its CMC portion of the BLA.
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. |
