Ready to declare a definitive comeback in two months, Immunomedics stops PhIII early, recruits new CEO
More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.
Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”
The turnaround is not exactly complete but it’s enough to win investors over, nearly doubling its shares $IMMU to $18.77.
The recommendation by the data safety monitoring committee means that Immunomedics doesn’t need to wait until a certain number of patients to progress before they begin analyzing the data.
The Phase III ASCENT study was designed to evaluate how its antibody-drug conjugate dubbed sacituzumab govitecan impacts progression-free survival, overall survival and response rates compared to chemotherapy.
The plan is to submit the revised statistical analysis plan to the FDA in a matter of hours, executive chairman Behzad Aghazadeh told Endpoints News Monday morning.
“More importantly, it’s not so much that we don’t have to wait any longer for patients to progress, the independent data safety monitor committee is indicating to us that the trial was successful,” he said.
He cautiously added that the experts on the committee appear to indicate that in addition to the primary endpoint in PFS, they are also seeing positive trends on other endpoints.
Julie Gralow, a Fred Hutch researcher who chaired the DSMC, called the results “remarkable” — a comment that inspired Cowen’s Phil Nadeau to note “there is little question that sacituzumab will soon become standard of care in the treatment of relapsed and refractory mTNBC.”
To be clear, none of that should factor into the FDA’s ongoing review of sacituzumab govitecan. Aghazadeh still expects an accelerated approval by June 2. After all, according to the company, the only issues stopping regulators from doing so the first time around had to do with manufacturing and other procedural matters discovered during inspections. Scott Canute, a board member who was tapped as executive director upon Pehl’s departure, has helped ensure remediation is in place to address those concerns.
On the other hand, despite the shortened timeline, a full approval wouldn’t come until 6, 9, or even 12 months from now.
Immunomedics has previously presented Phase II data suggesting a 33% response rate and a median duration of response of 7.7 months.
“It is 2 or 3 times higher based on what we would expect in chemotherapy,” Aghazadeh, who also manages Avoro Capital (formerly venBio Select Advisor), said. “For the response rate, generally we would expect high single-digit, low double-digit responses. And we would expect about 3 to 4 months of duration for chemotherapy.”
For Nadeau, it all bodes well for further clinical development of sacituzumab govitecan, with 2025 sales pegged at $1.2 billion:
With sacituzumab producing similar Ph. II data in r/r ER+/HER2- mBC and mTNBC, we think the ASCENT results partially de-risk sacituzumab’s development in r/r ER+/HER2- mBC. IMMU expects to complete enrollment in the Ph. III TROPiCS-02 study in ER+/HER2- BC this year with interim data (ORR) to be released not long after the completion of enrollment.
The responsiblity to realize all that — starting with a potential near-term launch — now falls on the shoulder of Semerjian.
Semerjian moved days ago from his last job as chief commercial officer of Ipsen in London and, in a sign of the times, “is sitting at home in so-called self quarantine to ensure that he is able to safely come to the company site on [his official start date of] April 16,” Aghazadeh said.