As Novartis preps for ASCO next week and the big reveal later this month for its CAR-T hope tisagenlecleucel (CTL019), the company says it is not looking for a major I-O deal, though does acknowledge that it is missing some key cancer therapies in its pipeline.
This is according to analysts at Leerink who sat down with the Swiss major’s exec team this week. In conversation with the firm, Novartis pointed out that it has 18 second-generation I-O agents in early-stage development, and therefore its management “does not see the need for a large I-O-driven acquisition.”
This includes its PDR001 (anti-PD-1) that has been pushed into phase 3 and is designed to work alongside its GSK cancer buys Mekinist (trametinib) and Tafinlar (dabrafenib) in BRAF-mutated melanoma.
Novartis said that while early data suggested lower than expected response rates, “expansion studies reveal activity comparable with existing agents.”
Leerink pointed out that management views PDR001 more as a “facilitator of its combination strategy”, rather than as a head-to-head competitor with other PD-1 agents.
It also of course has the leading CAR-T med tisagenlecleucel, which looks likely to become the first of this new cancer class to reach the market by fall, closely followed by biotech rival Kite and its CAR-T KTE-C19 (a.k.a. axicabtagene ciloleucel).
The rivals are targeting different indications for their first approvals. Kite’s FDA application and priority review covers the use of KTE-C19 in non-Hodgkin lymphoma (NHL). Novartis is seeking approval for tisagenlecleucel-T in kids and young adults with B-cell acute lymphoblastic leukemia (ALL).
But the indications are set to be ramped up for both over the coming years across a number of blood cancers, and with a price tag expected to be over $600,000, big blockbuster sales are also expected.
Novartis is also touting this week data showing its other CAR-T candidate, CTL119, when used with Janssen/Pharmacyclics’ Imbruvica (ibrutinib) produced complete responses in 8 out of 9 patients with CLL, also with no evidence of disease in their bone marrow at three months.
But while having the next-gen cancer class in its pipeline, it notes that it is missing other big classes, including IDO, BTK and PARP inhibitors. Management told Leerink these were “interesting agents” that it does not currently have in its portfolio.
But, the company suggested that it “was not necessary to acquire these to fill out its already broad oncology pipeline.”
It did, however, acknowledge that the lack of a PARP inhibitor was “a gap in its oncology portfolio,” but added that valuations were “too high to justify a major deal in the space,” a common complaint from Big Pharma in recent years.
This also comes as PARP player Tesaro is said to be seeking a sale from the Wall Street Journal, coming two months after getting approval for its cancer med Zejula (niraparib).
This is according to “people familiar with the matter,” who said the company had been scouting around for a potential “big deal” in recent weeks.