Emboldened by ASCO data, FDA etches speedy approval path for Iovance's cervical cancer therapy
Iovance’s promising data snapshot detailing the potential of its cervical cancer drug at ASCO has convinced the FDA to accelerate its path to approval.
On Tuesday, the drug developer said the US regulator has recommended that an ongoing mid-stage study of its experimental therapy may be sufficient to support an application to market LN-145 in patients with advanced cervical cancer.
“This feedback is encouraging. The ability to use the current study, as well as the Breakthrough Therapy designation recently granted to LN-145, allows us to plan on a path to BLA submission in the second half of 2020,” Iovance chief Maria Fardis said in a statement. The company’s shares climbed about 2.6% to $25.26 before the bell.
In order to support the application to market the biologic, Iovance will need to enroll between 75 to 100 patients in the ongoing trial, the California-based company said. The estimated enrollment of the study, called innovaTIL-04, prior to the FDA meeting was 59 patients, according to the clinicaltrials.gov database.
Jefferies analysts predicted the company will need about 6 months of follow-up after enrolling the last patient and suggested that Iovance could file with 75 patients in the middle of 2020 and with 100 patients by the fourth quarter. “We believe IOVA could file based on 75 patients given Keytruda received accelerated approval in advanced cervical cancer based on a PII trial enrolling 77 patients.”
In May, Iovance garnered enthusiasm after it reported data from 27 evaluable cases of advanced cervical cancer. The biotechnology company’s tumor infiltrating lymphocyte (TIL) therapy induced a 44% objective response rate (ORR) — including one complete response, 9 partial response and two unconfirmed partial responses. Merck’s Keytruda — the current standard of care in this patient population — was approved as a second-line cervical cancer therapy with a 14% ORR.
Jefferies’ Biren Amin estimated peak sales of $382 million for LN-145 by 2030 based on about 4600 second-line advanced cervical cancer patients and 50% market penetration, using a conservative per year price of ~$250,000 per patient (and no annual price increases).
LN-145 is also being tested for use in head and neck cancer.
In the early stages of cancer, the immune system attacks its predator by mobilizing lymphocytes to attack and infiltrate the tumor. However, the defensive ability of these tumor-infiltrating lymphocytes (TILs) is typically brief as cancer cells quickly mutate, evading detection. Iovance’s technology is engineered to unsheath the cloak of invisibility worn by cancer cells to supercharge TIL efficacy. The company first extracts TILs from the patient and expands them in a lab to the tune of billions. The amplification process eliminates the immune-suppressive environment created by the tumor and enhances the replication and activation of aggressive anti-tumor TIL. Once a surfeit of TILs has been cultured, the cells are re-infused into the patient.
Data presented at ASCO from another study showed Iovance’s lead experimental therapy, lifileucel, conferred an ORR of 38% (2 complete responses and 23 partial responses) in 66 consecutively dosed post-PD-1 patients with late-stage unresectable melanoma.
Iovance’s announcement on Tuesday is positive, but “largely inline with investor expectations post ASCO. This also expedites that cervical cancer timelines inline with the melanoma study, both of which are now expected to report final results and BLA filing in 2H20,” Cowen’s Boris Peaker wrote in a note.
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