Exelixis (EXEL) investor relations material

Zanzalintinib development and strategy

• Seven ongoing or planned pivotal studies are underway, aiming to establish leadership in colorectal cancer (CRC) and expand the Zanza franchise based on robust STELLAR-303 data showing survival advantage in third-line CRC.

• The third-line plus CRC market is valued at $1.5 billion, with Zanza offering a chemo-free, IO-containing option that demonstrates consistent benefit across patient subtypes.

• Additional data from the non-livermet subgroup, expected mid-year, will enhance discussions with providers and regulators, supporting a comprehensive label.

• Dose selection for Zanza is informed by extensive PK modeling and exposure-response analysis, with tailored dosing strategies for each study to optimize benefit-risk profiles.

• The goal is to shift the standard of care and improve patient survival, leveraging learnings from previous TKI development.

RCC and other pivotal trials

• STELLAR-304 aims to provide level 1 evidence for Zanza plus nivolumab in non-clear cell RCC, potentially defining a new standard of care in a space lacking large randomized studies.

• LITESPARK-034 and LITESPARK-033, in collaboration with Merck, are designed to address evolving treatment paradigms in RCC, focusing on future patient management and optimizing TKI use.

• The design of these trials considers the growing adoption of adjuvant pembrolizumab and the need to define optimal sequencing versus combination strategies.

Early-stage and pipeline initiatives

• STELLAR-311 is structured as a phase II/III trial in neuroendocrine tumors, using an efficient gating mechanism to assess early success and accelerate completion.

• STELLAR-316 targets MRD-positive early-stage CRC, offering intervention where current standard is watch and wait, with strong KOL and patient interest expected to drive brisk enrollment.

• The pipeline beyond Zanza is increasingly focused on biotherapeutics, especially ADCs, with a commitment to only advance programs that can define new standards of care and to discontinue those that do not meet this bar.