Puma Biotechnology Investor Presentation — January 2021

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Summary and conclusions

■ Neratinib is safe and tolerable in patients with advanced biliary tract cancers

with somatic HER2 mutations:

– Although the study did not meet its prespecified criteria for further expansion,

the antitumor activity of neratinib appears comparable to current standards

of care, with similar PFS and OS in heavily pretreated patients.

– A subset of biliary tract cancer patients had tumor shrinkage or extended

disease control, suggesting single-agent anti-tumor activity in this rare

– The major observed toxicities were manageable gastrointestinal adverse

events and were consistent with expectations.

– A limitation of the study is the small sample size and inclusion of poor

ECOG PS patients, leading to a high proportion of non-evaluable patients.

■ Analysis of co-mutations and copy number variations is ongoing and may

inform future combination strategies.

■ The authors would like to thank all patients and their families for participating in the

■ SUMMIT was sponsored by Puma Biotechnology Inc.

■ Puma Biotechnology Inc. funded medical writing/editing assistance for this poster,

which was provided by Miller Medical Communications Ltd.

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3. Lamarca et al. J Clin Oncol 2019;37(suppl; abstr 4003).