Novartis’ overhaul has hit its R&D group. For investors and market watchers, that puts an increased emphasis on key label expansions for a pair of cancer therapies.
On a Tuesday conference call, analysts spent much time grilling Novartis CEO Vas Narasimhan for details about breast cancer drug Kisqali’s recent positive topline readout in the postsurgery adjuvant setting. They also asked about the company’s progress on radioligand therapy Pluvicto.
The growing focus comes as both drugs reach an important juncture in their commercial lives. Meanwhile, Novartis just decided to chop 10% of its pipeline because of concerns over strategic fits and commercial potential, adding to the company’s urgency to grow sales of existing meds.
For Kisqali, sales from the CDK4/6 inhibitor reached $415 million in the first quarter. The performance came 22% above Wall Street’s expectations and represents an 81% increase versus the same period last year. Novartis attributed the growth to increased recognition of the drug’s life-extension benefit in metastatic breast cancer.
Still, that revenue haul is no comparison to what Novartis and some analysts view as a $6 billion market opportunity in the adjuvant setting.
Last month, Novartis said the closely watched NATALEE trial was successful in showing adjuvant Kisqali’s ability to prevent invasive disease from returning in HR-positive, HER2-negative early breast cancer at intermediate or high risk of recurrence. The company is now planning to file for FDA approval in the second half of 2023.
The NATALEE trial’s target population is about two to three times the size of Eli Lilly’s rival drug Verzenio in its own adjuvant indication, Narasimhan noted during the call. Thanks to the positive monarchE trial, Verzenio is currently allowed as an adjuvant therapy in high-risk patients with lymph node involvement.
Kisqali’s benefit was consistent in stage 2 and stage 3 patients, Narasimhan said during the call. But the CEO declined to offer more details when one analyst asked whether “consistent” meant similar magnitude of recurrence-free survival benefits across patient subgroups.
Detailed NATALEE data will give analysts a better idea on the portion of the $6 billion addressable market that Kisqali may be able to capture.
“The key driver will be how much uptake we can drive in the stage 2 patient population,” Narasimhan said. In those node-negative patients, “there is more reluctance amongst physicians to start patients on additional lines of therapy,” Narasimhan added. “But we believe that the data is strong enough overall that there should be broad use across both stage 2 to 3 patients at risk with breast cancer and including node-negative patients.”
Another closely watched asset at Novartis is Pluvicto. Despite a supply shortage and halt in new patient starts, the prostate cancer therapy raked in $211 million sales in the first quarter, up 18% versus last year's first quarter and beating Wall Street expectations by 11%.
Pluvicto has its own potential label expansion around the corner. A positive readout from the phase 3 PSMAfore trial could move the radioligand therapy up in the treatment sequence before patients get taxane-based chemotherapy. The pre-taxane setting would triple or quadruple the number of patients eligible for Pluvcito, by Novartis’ estimate.
But Novartis needs to first resolve its manufacturing bottleneck. The FDA just signed off Novartis’ manufacturing facility in Millburn, New Jersey, to supply commercial Pluvicto. Although the plant has started production, Novartis only expects to see a significant expansion in capacity in the second half the year, Narasimhan said.
In addition, Novartis is also preparing to file its Indianapolis facility with the FDA. It's also building automated production lines which Narasimhan said will add “substantial capacity.” Manufacturing capacity won’t be a problem when Pluvicto moves into the pre-taxane setting, the CEO said.
Meanwhile, new competition such as PSMA-targeted antibody-drug conjugates could challenge Pluvicto. For now, Narasimhan doesn’t see a threat from ADCs given Pluvicto’s overall benefit-risk profile. But earlier treatment settings are “another ballgame,” he said.
“I think we would have to find ways to expand the ability to administer radioligand therapies further into the community,” Narasimhan said. “There, I do think we would need to do quite a bit of additional work to expand that capacity.”
Besides Pluvicto and Kisqali, Novartis also saw 32% growth for heart drug Entresto, which surpassed anti-inflammatory disease therapy Cosentyx for the first time to become Novartis’ top-selling product. Entresto delivered $1.4 billion sales in the first quarter, whereas Cosentyx recorded $1.1 billion, a 4% decline.
Overall, Novartis’ innovative medicines sales grew 7% at constant currencies, reaching $10.6 billion. The Sandoz generics unit, which is on track to be spun off, pulled in $2.4 billion in net sales, an increase of 8%.