Launching a drug amid the pandemic is no cakewalk, but Immunomedics decided to do it anyway with first-in-class Trodelvy in triple-negative breast cancer—and it's drummed up some extra money to help.
The New Jersey biotech recently closed a $459 million stock offering to help commercialize Trodelvy, expand its clinical programs and scale up manufacturing.
For launching Trodelvy, the money will be invested in sales and marketing infrastructure and will “enhance our technology capabilities to support hybrid launch initiatives,” Usama Malik, Immunomedics’ chief financial and chief business officer, told FiercePharma in an email interview.
Approved in April as a treatment for TNBC patients who have already tried at least two other therapies, Trodelvy is launching right into the COVID-19 pandemic. Instead of holding off on the rollout until the healthcare environment normalizes, Immunomdecis made the first anti-Trop-2 antibody-drug conjugate (ADC) available immediately and treated the first commercial patient on April 29. But the marketing approach needs some adjustments from what the company had originally hoped for before an FDA rejection last year.
“Many of our interactions are virtual, where an interaction that might’ve been face to face in this time has been a video conference or a teleconference,” Immunomedics Chief Commercial Officer Brendan Delaney said during a conference call last week.
It’s obviously not an ideal situation because nothing replaces a face-to-face interaction, Delaney acknowledged. But the launch is so far meeting the company’s internal expectations, he said.
“Physicians are excited about the drug and they’re making time for our representatives to educate and they’re doing it proactively,” Delaney told investors on the call.
There’s no doubt about what Delaney described as a “groundswell of excitement” over the drug—it’s the first FDA-approved option in the third-line TNBC setting.
In a phase 1/2 study, Trodelvy shrank tumors in about one-third of patients and delayed the time to disease progression or death by a median 5.5 months. Historically, chemotherapies only trigger response rates of 10% or less, stalling progression for around 1.5 months to 2.5 months, Delaney previously told FiercePharma.
Immunomedics is targeting Tier 1 to 3 prescribers who cover 90% of the total addressable market, which is estimated to be around 8,000 to 9,000 patients a year in the third-line setting and 6,000 to 7,000 in the fourth line.
Moving toward that goal—which the company expects to happen with a ramp-up of two to three months—Immunomedics recently completed the national drug rebate agreement with the Centers for Medicare & Medicaid Services, winning mandatory Medicaid coverage for Trodelvy across the U.S. by July 1, three months ahead of schedule, Malik said. The pact is also a prerequisite for Medicare.
“Given TNBC more commonly affects younger women (median age of around 54), we expect to have significant private insurance coverage and a favorable coverage determination from all commercial plans,” he added.
Manufacturing was the factor that derailed Trodelvy’s first attempt at an FDA green light and was recently featured in another Form 483. To get its production up to standards, Immunomedics has hired manufacturing expert and AstraZeneca and Merck & Co. veteran John Stubenrauch as its global head of manufacturing.
Some of the proceeds from the public offering will also be used to scale up its supply chain and to cut manufacturing costs across all components of the ADC: antibody, drug linker and finished product.
Right now, the antibody used in Trodelvy is produced at Immunomedics’ own Morris Plains facility in New Jersey, and it’s working to get Samsung BioLogics approved as its second source. The company previously said it expects the New Jersey facility to supply around 12 million to 18 million doses, enough before the CDMO site comes online.
Thanks to early implementation of social distancing measures and other on-site monitoring, manufacturing operations have been minimally impacted by the pandemic to date, Malik said. But the company can't say that for all of its clinical development activities.
Immunomedics in late March said it was pausing enrolling of new patients in trials and activation of new sites. But at least its Trodelvy phase 3 confirmatory study, dubbed Ascent, has already stopped early after an independent data monitoring committee observed strong efficacy. In addition, following “persistent” requests from investigators, the phase 3 Tropics-02 study of Trodelvy in HR+/HER2- breast cancer will resume enrollment later this month at select sites that have been carefully vetted, according to Malik.
Immunomedics has a long list of clinical programs planned for Trodelvy. In bladder cancer, it’s running the Trophy U-01 trial, with a 100-patient cohort of platinum-eligible patients that was fully enrolled before COVID-19. It’s won an FDA fast-track designation in that indication and is planning to launch a phase 3 study “based on discussions with the FDA on a potential accelerated approval pathway,” Malik added.
Combination approaches are also being explored. It’s pairing Trodelvy with Merck’s Keytruda in newly diagnosed PD-L1-negative TNBC, as well as in refractory patients with PD-L1-positive, HR+/HER2- breast cancer.