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Pluvicto Sales Ramp up, Kisqali Gains Continue in Q3 for Novartis


NEW YORK – Novartis' radioligand therapy Pluvicto (177Lu-PSMA-617 or lutetium vipivotide tetraxetan) is off to a strong start in the first full quarter since its launch, grabbing 14 percent of new prescription sales in the post-taxane metastatic castration-resistant prostate cancer setting and bringing in total sales of $80 million for the third quarter.

The US Food and Drug Administration approved Pluvicto in March for patients with progressive mCRPC whose tumors express prostate-specific membrane antigen (PSMA). At the same time, the agency approved Novartis' gallium-68-labeled imaging product Locametz (gallium Ga 68 gozetotide) as a companion diagnostic to identify mCRPC patients with PSMA-positive lesions who are eligible to receive Pluvicto.

"We're seeing a very rapid launch uptake for this brand in the third-fourth line castrate-resistant, metastatic prostate cancer segment," said Novartis CEO Vas Narasimhan in a conference call Tuesday morning after the firm released its third quarter results.

While Novartis spotlighted several precision oncology products with strong sales for the quarter, overall, it saw a 4 percent drop in sales from $13.03 billion to $12.54 billion and a drop in net income from $2.76 billion to $1.58 billion compared to the third quarter of 2021. (Excluding an income contribution from Roche, its Q3 2021 net income was $2.53 billion.) Novartis Chief Financial Officer Harry Kirsch attributed the decreased income to restructuring costs, "mainly due to the implementation of our previously announced realigned organization model."

Part of that reorganization includes the spinoff of its generics and biosimilars business Sandoz into a publicly traded, standalone company, as the firm maintains a focus on five core therapeutics areas going forward including solid tumors and hematology, cardiovascular, immunology, and neuroscience.

Narasimhan said that Novartis has 120 centers actively ordering Pluvicto and over time expects that number to grow to 350 to 400 as it increases manufacturing capacity in anticipation of new data potentially supporting expansion of indications for the drug. "What's critical for us is, as we move into the period where we hope to have a positive readout in the earlier lines, we would need additional capacity to be able to service that earlier-line indication," said Narasimhan.

Currently, Novartis expects to have its Millburn, New Jersey manufacturing facility online in early 2023 and a facility in Indianapolis up and running in the middle of 2023. Once the Millburn facility comes online, Narasimhan noted the company would be "well positioned" for the demand surge in that new indication.

By the end of 2022, Novartis is expecting a readout from its PSMAfore Phase III trial of Pluvicto in taxane-naïve patients with progressive mCRPC compared with androgen receptor-directed therapy. That trial will evaluate overall survival in about 450 patients randomized to Pluvicto or the comparator arm for up to 43 months, as well as time to radiographic progression, progression-free survival, and biochemical response as measured by prostate-specific antigen (PSA), among other endpoints.

In the Phase III PSMAddition trial, Novartis is comparing treatment with Pluvicto combined with the standard-of-care therapy to standard-of-care therapy alone in patients with metastatic hormone-sensitive prostate cancer. The endpoints of that trial will include overall survival assessed up to 50 months, prostate-specific antigen 90 (PSA90) response, progression-free survival, and time to development of mCRPC. Novartis expects results from that trial in 2024.

According to Narasimhan, Novartis is focusing on larger volume clinical centers in the first phase of its launch of Pluvicto. "If we were able to open it up even further in terms of the number of centers, we would expect even higher volumes for this medicine, given the overall demand that we're seeing," said Narasimhan. However, the company is taking a stepwise approach, ensuring that it can service the first level of large clinical centers fully before moving on to others.

Narasimhan contrasted that with the launch of its neuroendocrine-targeted radiopharmaceutical Lutathera (lutetium lu 177 dotatate), where, because of lower volumes and neuroendocrine tumors being treated at a limited number of centers, demand was not as high. He pointed out that one of the dynamics that is important related to Pluvicto is broadening the use of PET imaging to identify patients with an elevated PSA to determine the extent of metastasis. "If you identify these patients through the PET ligand, you're more likely to use a radioligand because you've seen the tumor and the therapy can target what you see," he said.

Sales of Novartis' CDK4/6 inhibitor Kisqali (ribociclib) grew 49 percent to $327 million compared to the third quarter of 2021 with growth in new prescriptions in the US metastatic breast cancer population over the course of the year from 12-13 percent to 26 percent as of August. "That's really on the back of the strong data that we have with respect to [overall survival] across all of the metastatic lines. It's the only CDK4/6 [inhibitor] with overall survival benefit across three Phase III studies," said Narasimhan. "We also have strong data with respect to quality of life."

The Novartis presentation highlighted a steady decrease in monthly new prescription share for Kisqali's main competitor, Pfizer's Ibrance (palbociclib) since September 2021.

Data from the Phase III MONALEESA-2 study reported at the American Society of Clinical Oncology's annual meeting in June showed an overall survival benefit for Kisqali plus letrozole compared to placebo plus letrozole in first-line hormone receptor-positive, HER2-negative metastatic breast cancer. Results from the MONALEESA-3 and MONALEESA-7 trials have similarly shown benefits in the first-line setting for metastatic breast cancer.

Novartis is now awaiting results from the HARMONIA Phase III head-to-head study of Kisqali versus Ibrance in patients with advanced breast cancer and the NATALEE Phase II study of Kisqali as adjuvant therapy in patients with hormone receptor-positive, HER2-negative early breast cancer. 

Narasimhan said that Novartis has not yet received any feedback from the steering committee for NATALEE with respect to the first interim analysis. "When that feedback becomes available, if it indicates any action on our part, we will, of course, inform the markets," Narasimhan said.

Sales of STAMP inhibitor Scemblix (asciminib) were $41 million in the third quarter of 2022 compared to $31 million in the second quarter and $25 million in the first quarter. Its share of new patient prescriptions in chronic myeloid leukemia started at 20 percent across all lines of therapy in the first quarter and have decreased to 13 percent in the third quarter. It took 39 percent of new prescriptions among third-line patients. "That new patient share growth has slowed a bit, as we would have expected, because we need patients to switch off of therapies that are currently in line to typically be moved to Scemblix," said Narasimhan.

In August, the European Commission approved Scemblix for patients with previously treated Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) who have received two or more prior tyrosine kinase inhibitors. In the Phase III ASCEMBL trial, patients who received Scemblix had an improved major molecular response rate compared to those who received Pfizer's Bosulif (bosutinib). Scemblix received accelerated approval from the FDA in that setting in 2021, and at the same time the agency granted full approval for the drug for Ph+ CML-CP patients whose cancers harbor a T315I mutation. A Phase III trial of Scemblix in patients with newly diagnosed Ph+ CML-CP is enrolling "ahead of schedule," according to Narasimhan, and that data is expected in the second half of 2024. "The critical element now will be our ability to move into the earlier lines," he said.