Late last week, the US Food and Drug Administration (FDA) approved anti-CD19 monoclonal antibody tafasitamab for use in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The second-line approval positions Incyte and its partner MorphoSys to compete with drugs including the CAR-T therapies sold by Gilead Sciences and Novartis.
Talking to investors on a second quarter results conference call this week, Incyte EVP Barry Flannelly acknowledged “the challenges presented by COVID-19 pandemic are not ideal” for new launches. Yet, Flannelly nonetheless said Incyte is “very well positioned for a successful launch.”
Flannelly’s confidence that Incyte and MorphoSys can successfully introduce a new product at a time when in-person interactions between sales reps and physicians are well down is underpinned by his experience of the Pemazyre launch.
The FDA approved Incyte’s fibroblast growth factor receptor inhibitor Pemazyre for use in adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma in April. As such, Incyte has experience of launching cancer drugs in the US in a time of pandemic-induced restrictions. The experience has shown Incyte what tasks can be done well virtually.
“We learned things that really work that we'll keep doing. Virtual programs, virtual visits, virtual speaker programs, virtual advisory boards, all of these things work. For Pemazyre, we really targeted the physicians that we wanted to target ahead of time that we know are GI docs that specialize in cholangiocarcinoma, liver cancer and so forth. And we were able to reach them virtually through our representatives,” said Flannelly.
In the second quarter, which spanned April, June and July, Pemazyre generated sales of $4 million for Incyte. The biotech will be looking to grow that figure significantly in the coming quarters but has not provided guidance on its expectations.
Incyte will apply experience gained in the launch of Pemazyre to try to make a success of a product that carries greater expectations. Morningstar analysts predict peak Pemazyre sales of $500 million, making them among the bullish observers of Incyte. The Morningstar analysts model peak US sales of tafasitamab of $3 billion.
Analysts have placed such blockbuster expectations on tafasitamab, which is being sold under the brand name Monjuvi, after seeing data that suggests it can claim a sizable slice of the busy DLBCL market.
Monjuvi had a median duration of response of 21.7 months in its pivotal trial, exceeding the result achieved by Roche’s antibody-drug conjugate Polivy and suggesting the drug can achieve CAR-T-like efficacy without the manufacturing complexity.
Unlike CAR-T, Monjuvi is given without the intensive conditioning regimens that limit eligibility for cell therapy treatment to younger, fitter patients. The median age of subjects in the pivotal Monjuvi trial was 71 years, compared to 56 years and 58 years, respectively, in key studies of the CAR-T therapies Kymriah and Yescarta. The median age in Polivy studies ranged from 66 years top 69 years.