On 4 February 2024, Novartis announced its acquisition of the prominent biopharmaceutical company MorphoSys AG. This deal provides Novartis with two late-stage pipeline therapies, pelabresib and tulmimetostat. The most prominent of the two is the highly anticipated first-in-class bromodomain (BET) inhibitor pelabresib, which is currently undergoing a Phase III clinical trial for treatment-naïve myelofibrosis (MF) patients in combination with Incyte/Novartis’s Jakafi/Jakavi (ruxolitinib), a Janus kinase inhibitor (JAKi). The disease is characterised by severe anaemia and an enlarged spleen. JAKis have emerged as a primary treatment option for patients with various types of MF within the last decade. This drug class has also created some difficulty in the current treatment pathway as patients who discontinue existing JAKi treatment consistently have poor survival durations and there is a lack of alternative treatment options.
The results of the Phase II MANIFEST trial assessing pelabresib were published early last year. The trial recruited 84 JAKi treatment-naïve patients with MF and primarily assessed spleen volume reduction of ≥35% (SVR35). At 24 weeks, 68% of patients achieved an SVR35, and the most common grade ≥3 events were thrombocytopenia (12%) and anaemia (35%). The Phase III MANIFEST-2 trial also met its primary endpoint. The data demonstrated that pelabresib + Jakavi was superior to placebo + Jakavi, achieving 66% and 35% SVR35 response rates at 24 weeks (p<0.001), respectively. Furthermore, a key secondary endpoint of a 50% reduction in total symptom score showed the pelabresib combination’s superiority to the placebo combination in intermediate-risk patients, but not in the overall patient population. This will likely limit pelabresib’s label to intermediate- or high-risk MF individuals. Clinical data regarding Jakavi has shown that a reduction in spleen volume was associated with prolonged survival in MF patients. When used in combination with pelabresib, this effect will likely be enhanced. Pelabresib is also being evaluated in clinical trials for chronic idiopathic MF and acute myelocytic leukaemia. The data from the MANIFEST and MANIFEST-2 trials looks promising and has been welcomed by physicians due to the lack of therapeutic options for patients with MF. GlobalData’s Global Annual Consensus Forecast estimates pelabresib to reach $641m in sales by 2029.
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Tulmimetostat, another pipeline asset acquired in the portfolio, is being appraised for its novel mechanism of action targeting EZH2. Mutations in EZH2 have been associated with solid tumours and blood malignancies due to its ability to inhibit tumour suppression, allowing cancer growth. The Phase II trial looked at various solid malignancies (n=62), including patients with urothelial and endometrial cancer. One cohort, peripheral T-cell lymphoma patients, were tested for an EZH2 hotspot mutation before treatment. Early results indicate that while there are some partial and complete responses, serious treatment-related adverse events (AEs) were high (32.3%), with 8.1% of patients discontinuing treatment due to these AEs.
MorphoSys’s only marketed product Monjuvi (tafasitamab) will not be included in the deal, as the US marketing rights were purchased by its collaborator Incyte for $25m. Monjuvi is a CD19 monoclonal antibody that is currently used in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients who are not eligible for autologous stem cell transplantation. The absence of US market rights to Monjuvi will be a slight but not insignificant blow to Novartis, as GlobalData’s Analyst Consensus Forecast estimates US sales of the drug to reach $256m by 2029.
Ultimately, the acquisition is not entirely driven by the portfolio, and Novartis is seeking to use its previous collaborative experience with MorphoSys to expand its developments internally. Despite the development of pelabresib looking promising, other pipeline agents in the portfolio do not seem to hold as much promise, and it is unclear if the potential sales of these agents will make up for the $2.9bn cost associated with the acquisition.
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