Shares of Immunomedics (IMMU) skyrocketed after the company said its late-stage ASCENT study would be halted on positive data in breast cancer. Separately, the company announced that Harout Semerjian has been appointed as president and chief executive officer.
TRIAL TO BE HALTED FOR EFFICACY: Immunomedics is stopping its Phase 3 ASCENT trial due to “compelling evidence of efficacy” demonstrated in patients with advanced, triple-negative breast cancer, or TNBC, the company said on Monday. The decision to halt the study involving sacituzumab govitecan was based on a unanimous recommendation by the independent Data Safety Monitoring Committee following a review of the data.
ASCENT is a Phase 3 confirmatory study designed to validate the safety and efficacy data of sacituzumab govitecan observed in a Phase 2 study of heavily pretreated patients with metastatic TNBC. The primary endpoint for the study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others. A biologics license application resubmission seeking accelerated approval of sacituzumab govitecan for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease is currently under U.S. Food and Drug Administration review, with a PDUFA target action date of June 2. The FDA previously granted Breakthrough Therapy Designation for sacituzumab govitecan in this disease setting.
In a statement, Julie R. Gralow, MD, Jill Bennett Endowed Professor of Breast Cancer, University of Washington School of Medicine and Member, Fred Hutchinson Cancer Research Center said that the "remarkable results we observed across multiple endpoints in the ASCENT study warranted early discontinuation of the trial and are indicative of a potential major advance in the treatment of this devastating disease that affects younger women and African American women at higher rates. I look forward to the release of the full and final analyses of these study data when they are available for public presentation."
APPOINTMENT OF PRESIDENT AND CEO: On another note, the company said it has appointed Harout Semerjian as president and CEO, effective April 16. Most recently, he served as Executive Vice President, Chief Commercial Officer at Ipsen (IPSEY), where he was accountable for the worldwide commercialization and portfolio strategy across oncology, neurosciences and rare diseases, as well as leading specialty operations across Europe and International markets, overseeing 2,200 employees in over 30 countries.
WHAT'S NOTABLE: Last week, Immunomedics shares plunged on concerns related to the FDA's Form 483 observations from a recent inspection of the company’s New Jersey facility. While the deficiencies cited raise the risk of a delay, management continues to anticipate sacituzumab's approval on or before the FDA action date in the second quarter, Cowen analyst Phil Nadeau contended, adding that Immunomedics responded to the FDA within two weeks with a plan to rectify the issues. Piper Sandler analyst Joseph Catanzaro said that the issuance of the FDA's Form 483 observations to Immunomedics is not surprising, but whether the issues are addressable via a written response and/or post-marketing commitments before the June 2 PDUFA is critical. Catanzaro pointed out that the company has provided a detailed response to the issues cited in the 483, which are largely in relation to improvements across quality systems and procedures and that a number have already been addressed.
EARLY STOP A 'CLEAR POSITIVE': On Monday, Goldman Sachs analyst Paul Choi called the early stop to the sacituzumab govitecan Phase 3 study based on the the Data Safety Monitoring Committee view of compelling efficacy a "clear positive" and "an encouraging development." However, he awaits additional clarity on the manufacturing and procedural issues outlined by FDA inspectors in the recent Form 483 disclosed last week, Choi said. Jefferies analyst Chris Howerton called the early trial stop a "major de-risking development. He said the company believes the FDA will make the accelerated approval decision by the PDUFA date of June 2 versus wait 6-9 months for the detailed ASCENT data for final approval. He also sees the new 483 inspection form as becoming "less relevant" for approvability, but said it will likely dictate the timing of accelerated approval.
Wells Fargo analyst Jim Birchenough upgraded Immunomedics to Overweight from Equal Weight with a price target of $34, up from $12. With the early study halt for compelling efficacy across several endpoints, a significant overhang around sacituzumab govitecan approval has been lifted, Birchenough said. The analyst expects the drug to ultimately become a standard of care for relapsed/refractory triple negative breast cancer. While the recent Form 483 observations remain a risk to approval by the June 2 action date, Immunomedics' upside potential outweighs potential downside risk, Birchenough contended.
Piper Sandler analyst Joseph Catanzaro raised the firm's price target on Immunomedics to $30 from $25, saying that while near-term concerns around the recent FDA Form 483 will likely remain, and feedback suggests that a near-term approval is not without risk, the positive ASCENT result "is much more important to sacituzumab's long-term value."
PRICE ACTION: In morning trading, Immunomedics shares spiked 104% to $19.18.
Acquired by GILD
+9.62 (+102.45%)
Ipsen
+ (+0.00%)