NEW YORK – Novartis is gearing up to meet threefold growth in patient demand for Pluvicto (vipivotide tetraxetan), betting that the radiopharmaceutical will gain US regulatory approval in an earlier-line prostate cancer indication in the first half of 2025.
Work is underway to lay the foundation for launching Pluvicto in the population included in the pivotal PSMAfore study, Novartis CEO Vas Narasimhan said on a conference call Tuesday morning to discuss the firm's third quarter financials.
The prostate-specific membrane antigen (PSMA)-directed radiopharmaceutical is currently approved for patients with previously treated, PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Novartis submitted data to the US Food and Drug Administration from the PSMAfore study seeking to expand the treatment's indication to PSMA-positive mCRPC patients who have not received prior chemotherapy.
If the FDA approves the drug in this setting, it "would triple the number of patients eligible for Pluvicto," Narasimhan said. In Q3 2024, sales of Pluvicto were $386 million, up 51 percent from Q3 2023. After accounting for a one-time price adjustment in Europe, the radioligand's sales grew 37 percent over the same period.
To get ready for a potential approval in the earlier-line setting, Novartis has bolstered its sales force and launched a direct-to-consumer marketing strategy to drive adoption among patients and healthcare providers. Novartis now has 530 sites in the US that can administer Pluvicto, and Narasimhan said the firm plans to "expand deeper into the community setting step by step."
Novartis' plans to expand its radiopharmaceutical treatment capacity include building two additional manufacturing facilities. According to Narasimhan, Novartis will be able to manufacture radiopharmaceuticals other than Pluvicto at these sites, as well. For instance, Novartis has a B7H3-targeted, actinium-based radioligand therapy; a HER2-directed radioligand therapy; and a folate-directed radioligand therapy. All of these other radioligand treatments have either just entered, or are about to enter, clinical trials.
Meanwhile, during Q3 2024, Novartis' other FDA-approved radiopharmaceutical, Lutathera (lutetium Lu 177 dotatate), brought in $190 million, up 19 percent from Q3 2023. The somatostatin receptor (SSTR)-directed radioligand is approved for adult patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
Non-Radiopharmaceutical Q3 results
For the three months ending Sept. 30, Basel, Switzerland-based Novartis' overall revenue increased 9 percent to $12.82 billion from $11.78 billion in Q3 2023, outperforming the consensus revenue estimate of $12.76 billion. On a constant currency basis, Novartis' revenue was up 10 percent versus Q3 the prior year.
Scemblix (asciminib), a STAMP inhibitor that Novartis markets for certain chronic myeloid leukemia patients, brought in $182 million during Q3 2024, up 72 percent over Q3 2023. Early on in the third quarter, the FDA granted priority review to Novartis' application seeking approval for Scemblix as a treatment for Philadelphia chromosome-positive, newly diagnosed CML patients in the chronic phase. On Tuesday, shortly after Novartis reported its Q3 earnings, the FDA granted accelerated approval for Scemblix in this setting.
Sales of Novartis' CDK4/6 inhibitor Kisqali (ribociclib) were $787 million in Q3 2024, up 40 percent from Q3 2023. The agent, which was already approved for hormone receptor-positive, HER2-negative metastatic breast cancer, netted a broader FDA approval in early-stage breast cancer patients in September. The agency approved Kisqali combined with an aromatase inhibitor in stage II and III breast cancer patients at a high risk of recurrence based on the results of the Phase III NATALEE clinical trial. According to Novartis, this recent approval roughly doubles the eligible patient population for Kisqali.
"The early feedback we're getting from the market is strong," Narasimhan said about the impact of the broader Kisqali approval. "The early scripts we're seeing show a very strong trend, and we look forward to building upon that. … We now have what we believe to be the perfect positioning that we would want for Kisqali to succeed in the long run."
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) also recently recommended Kisqali's approval in this patient population.
The firm's BRAF/MEK inhibitor combination, Tafinlar plus Mekinist (dabrafenib plus trametinib), brought in $534 million in Q3 2024, up 11 percent compared to Q3 2023.
MorphoSys acquisition impact
While Novartis focused much of its conference call on the assets it saw as steady growth drivers for the quarter, the Swiss drugmaker also disclosed some negative news in its quarterly filings with the US Securities and Exchange Commission. Early in 2024, Novartis acquired the German biotech MorphoSys for $2.9 billion to gain access to several oncology assets.
However, according to information Novartis disclosed in an SEC filing, that acquisition hasn't yet brought the value it was expecting. Instead, Novartis wrote down an $800 million impairment of MorphoSys-related goodwill due to a delayed regulatory filing for the firm's JAK/STAT inhibitor pelabresib in myelofibrosis. Novartis was originally planning to seek approval for the agent based on Phase III data, but safety data from the trial delayed filing plans.
Novartis' net income in Q3 2024 was $3.19 billion, or $1.58 per share, compared to $1.51 billion, or $.73 per share, in Q3 2023. The firm said its core EPS was $2.06 for the quarter, surpassing analysts' average estimate of $1.96.
For the full year, Novartis raised its guidance. The firm is expecting net sales to grow in the low double digits, whereas before it was expecting high single-digit to low double-digit growth.