To hear MorphoSys CEO Jean-Paul Kress tell it, the company and partner Incyte have a potential blockbuster in the making in the newly approved diffuse large B-cell lymphoma drug Monjuvi. But first, the companies need to navigate through a pandemic for the launch.
Monjuvi brought in sales of €18.5 million ($22 million) in 2020 after earning its FDA nod in August, largely in line with industry watchers’ expectations. For 2021, the company’s projecting total revenues of €150 million to €200 million.
That means around €84 million to €134 million from Monjuvi sales, well below a previous estimate of €157 million, which was already about a quarter below consensus, SVB Leerink analyst Geoffrey Porges said in a recent note after crunching the numbers.
Launching during a pandemic
By the end of 2020, Monjuvi, as the first drug specifically approved for second-line DLBCL, had reached 400 care sites, with “a prompt uptake in academic centers and a growing momentum in community,” Kress said in an interview.
MorphoSys and Incyte have reached a roughly 50% share of voice for Monjuvi in the DLBCL space, meaning about half of all engagements with healthcare practitioners in this field are coming from reps promoting the CD19 antibody drug.
Doctors are talking up the drug’s long duration of response and easy accessibility, as the drug has obtained reimbursement and payer coverage with “no notable hurdles,” Kress said. Compared with existing CD19-directed CAR-T therapies, which require hospitalization and strict safety monitoring, Monjuvi’s simple intravenous infusion offers an advantage, he added.
RELATED: In a first, MorphoSys, Incyte win Monjuvi FDA nod in lymphoma to challenge Roche’s Polivy
Long-term follow-up from the phase 2 L-Mind trial, which earned Monjuvi its FDA go-ahead, showed a combo of Monjuvi and Bristol Myers Squibb’s Revlimid shrank tumors in 57.5% of previously treated patients, with responses lasting for a median 34.6 months. Among those Monjuvi helped, 71.3% were still seeing benefit at the two-year mark, according to data presented at the American Society of Hematology's annual meeting in December.
A lymphoma expert RBC Capital Markets recently interviewed suggested Monjuvi’s real-world experience is consistent with the clinical trial data. The expert had previously projected that the drug would be saved for sicker patients, but he’s now increasingly using Monjuvi sooner, even for healthier patients.
“[A]lthough the efficacy may take time to ramp up, responses are ultimately better than on [Roche’s] Polivy, and the drug is better tolerated,” a team of RBC analysts summarized in a recent note. Polivy is only approved as a third-line treatment, but physicians have been using it earlier.
While the initial commercial efforts have progressed well, COVID-19 poses a challenge, threatening a slow launch of Monjuvi for its first full year on the market, Kress said.
Thanks to the pandemic, MorphoSys anticipates “variability” for Monjuvi’s performance in 2021, hence the relatively big gap between the two ends of its revenue forecast.
To cope with the situation, the marketing team has been using digital tools for engaging with doctors. A top priority for the team is appropriately educating prescribers on the new two-year data, Kress added.
A backbone therapy for all lines of DLBCL
MorphoSys and Incyte are eyeing peak Monjuvi sales of €500 million to €700 million for the current second-line relapsed/refractory DLBCL indication in the U.S. alone.
But to turn the drug into an asset with multi-billion sales, the pair is looking at newly diagnosed patients, too. Early results unveiled at ASH 2020 from the phase 1b firstMIND trial showed the addition of Monjuvi and Revlimid on top of the widely used R-CHOP regimen—which contains Roche's Rituxan and steroid prednisone, along with a medley of chemo drugs—didn’t lead to any unexpected serious side effects, and that the complex cocktail triggered a response in 91% of patients.
Encouraged by that early result, the companies are prepping for a pivotal trial, dubbed frontMIND, comparing the seven-drug combo with traditional R-CHOP therapy in newly diagnosed patients at high risk of relapse. That study will likely require three to four years to read out meaningful survival data, Porges noted in December.
Kress pointed out that among the about 30,000 new annual DLBCL cases in the U.S., about half of the patients aren’t cured and may relapse or become refractory to first-line treatment, stressing the need for better front-line options.
But in expressing “cautious optimism” about the first-line setting, analysts at RBC argued that while Monjuvi’s safety profile can allow for easy addition to R-CHOP, “the efficacy hurdle remains tough to clear.” The 91% response rate the new Monjuvi combo posted in the phase 1b trial was actually in line with R-CHOP’s performance alone.
More competition is brewing for Monjuvi down the line, too. Polivy, Monjuvi’s unofficial competitor in second-line treatment, is expected to report front-line DLBCL data from the phase 3 Polarix trial this year.
RELATED: Roche's Polivy gets thumbs-up from England's cost watchdog after earlier rejection
Physicians are also getting excited over the potential of CD20xCD3 bispecific antibodies, the RBC team noted. There, Polivy maker Roche will report pivotal data for its candidate glofitamab in third-line DLBCL this year.
MorphoSys has a countermeasure in place. Last November, it signed on Xencor to combine the latter’s CD20xCD3 drug plamotamab with Monjuvi for DLBCL and follicular lymphoma. It's also pairing Monjuvi with Incyte’s PI3k inhibitor parsaclisib in various blood cancers.
The hope is that Monjuvi could be “a backbone therapy for DLBCL in any potential line” of treatment, Kress said. The backbone strategy means that the arrival of potential new modalities could serve to Monjuvi’s advantage, rather than as potential competition, he said.
New drugs will keep coming, “but if you’re part of the equation, you broaden your horizon and your long-term position,” he added.