Novartis lays out catch-up plan in immuno-oncology fueled by new-gen treatments

Jay Bradner, president of the Novartis Institutes for BioMedical Research (NIBR)

Novartis is often said to be lagging behind the leaders in immuno-oncology, but insisted today it has "a leading, if not THE leading" R&D portfolio this emerging field.

Immuno-oncology represents an "extraordinary revolution" in cancer medicine but the approach remains in its infancy, said Jay Bradner, president of the Novartis Institutes for BioMedical Research (NIBR), during the firm's fourth-quarter press conference today.

"The majority of patients—even with those diseases that might respond to this medicine—don't," he said, and the first-generation of checkpoint inhibitors "provide hope, but do not provide a cure." Moreover, a significant number of patients need to discontinue therapy due to adverse events, added Bradner.

Novartis is aiming to bring together a stable of compounds that will cover as many "critical nodes" in as possible among the mechanisms that allow cancers to evade the immune system as it tries to catch up with the current leaders in immuno-oncology—Bristol-Myers Squibb, Merck & Co, and Roche—which all have checkpoint inhibitors on the market.

Novartis only really got going in immuno-oncology at the start of 2015 when it set up a dedicated research team led by cancer vaccine pioneer Glenn Dranoff.

Right now, Novartis is sitting on around 18 immuno-oncology compounds in its pipeline, spanning immune priming drugs, T-cell engineered therapies, T-cell modulators and compounds that affect the tumor microenvironment, and it expects to start 20 exploratory immuno-oncology in the coming weeks.

The company is "in the catbird seat" when it comes to combining these drugs with gene-targeted therapies," said Bradner, who claimed this should deliver the company a "leadership position in oncology."

"Data emerging over the next 12-18 months from Novartis and competitor trials will inform the most impactful paths forward," he told journalists.

Novartis' lead candidate in the immuno-oncology category is CAR-T therapy CTL019, which is due to be filed for pediatric acute lymphoblastic leukemia (ALL) patients shortly, with a follow-up marketing application in diffuse large B-cell lymphoma (DLBCL) due before the end of the year.

With its first CAR-T candidate heading for a possible approval and launch this year, the drugmaker is also stepping up investment in manufacturing at NIBR, said Bradner.

"Unlike checkpoint inhibitors these are definitive medicines. With an 82% overall response rate and many patients free of disease five years later, there's a lot to be learned from this 'first blush' of CAR-T cell therapy," he concluded.

The company also said it was seeking out smaller targets with early-stage candidates to top up its pipeline, while reiterating its $2 billion to $5 billion range for any buyout deals. It was up nearly 2% premarket this morning.