Shares of Iovance Biotherapeutics (NASDAQ: IOVA) roared 50% higher last month, according to data provided by S&P Global Market Intelligence. The surge started when the biopharma announced a pair of promising midstage updates for its immunotherapy pipeline at the American Society of Clinical Oncology (ASCO) annual meeting after the stock market closed on the last day of May.
The encouraging results fueled speculation of a possible takeover. While no specific suitor was identified or rumored to be circling Iovance, the chatter picked up in mid-June when Pfizer announced its intention to acquire Array BioPharma for $11.4 billion. Excitement from an acquisition spilling over to peers isn't too surprising, but investors shouldn't necessarily expect a buyout. And Iovance appears well positioned on its own.
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At ASCO, Iovance presented data showing that LN-145 proved effective in treating advanced cervical cancer and that lifileucel proved effective in treating advanced melanoma. Both drug candidates are based on tumor-infiltrating lymphocyte (TIL) technology that has demonstrated promise in treating various solid-tumor cancers in cell culture and animal studies. Clinical results show the promise is translating to humans, too.
LN-145 had yet to reach a median duration of response (DOR) at the 7.4-month median follow-up with patients. Fellow Motley Fool contributor Keith Speights says that's impressive considering the DOR of current second-line treatments for advanced cervical cancer is about four months. Furthermore, the drug candidate demonstrated a complete response rate (read: patients that see no evidence of disease after treatment) of 11%.
The drug was recently granted Breakthrough Therapy Designation, which will allow the phase 2 data reported at ASCO to be included in an application for marketing approval. While Iovance still must complete a phase 3 trial, the designation will speed up regulatory matters quite a bit, perhaps allowing an application for approval to be filed as soon as the second half of 2020.
Lifileucel also had yet to reach a median DOR at the 8.8-month median follow-up with patients. Two complete responses were reported in that study. Both metrics are impressive considering advanced melanoma is a notoriously difficult cancer to treat.
Iovance Biotherapeutics is one of the more promising companies in the immunotherapy space. In addition to promising results for LN-145 and lifileucel as stand-alone treatments, there's tremendous potential to one day explore combinations with other approved drugs to see if patient responses can be improved. Of course, first things first: The company has to wrap up ongoing clinical trials, move to late-stage studies, and maintain promising results.
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