Celcuity | Cancer Therapies | Scientific Presentations

Gedatolisib, a pan-PI3K/mTOR inhibitor, shows superior potency & efficacy relative to other PI3K/AKT/mTOR pathway inhibitors in breast cancer models

Stefano Rossetti, Aaron Broege, Adrish Sen, Salmaan Khan, Ian MacNeil, Jhomary Molden, Igor Gorbatchevsky, Brian Sullivan, Lance Laing

2023 San Antonio Breast Cancer Symposium (SABCS)

Phase 1b study of gedatolisib plus palbociclib and endocrine therapy in women with hormone receptor positive advanced breast cancer: updated results in treatment naïve patients

Hope S. Rugo, Robert Wesolowski, Erica M. Stringer Reasor, Hyo Han, Jennifer M. Specht, E. Claire Dees, Peter Kabos, Ulka Vaishampayan, Seth A. Wander, Janice Lu, Keerthi Gogineni, Alexander Spira, Anne F. Schott, Maysa Abu Khalaf, Sarah C. Mutka, Samuel Suzuki, Igor Gorbatchevsky, Rachel M. Layman

2023 ESMO Breast Cancer Annual Congress

Gedatolisib, a well-tolerated pan-PI3K/mTOR inhibitor, exhibits potent therapeutic effects on gynecological cancer models regardless of their PI3K pathway mutational status

Stefano Rossetti, Aaron Broege, Ian MacNeil, Ben Rich, Jhomary Molden, Brian Sullivan, Lance Laing

2023 American Association for Cancer Research

A Phase 3 study of gedatolisib plus fulvestrant with and without palbociclib in patients with HR+/HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor plus a non-steroidal aromatase inhibitor (VIKTORIA-1)

Sara Hurvitz, Fabrice Andre, Massimo Cristofanilli, Giuseppe Curigliano, Antonio Giordano, Hyo Han, Miguel Martin, Barbara Pistilli, Hope Rugo, Robert Wesolowski, Samuel Suzuki, Sarah C. Mutka, Igor Gorbatchevsky, Sibylle Loibl

2023 American Association for Cancer Research

Therapeutic effect of gedatolisib, a pan-PI3K/mTOR inhibitor, on prostate cancer models differing in PI3K or PTEN mutational status

Adrish Sen, Salmaan A. Khan, Ian A. MacNeil, Benjamin E. Rich, Jhomary S. Molden, Laura N. Davis, Stefano Rossetti, Aaron M. Broege, Lance G. Laing

2023 ASCO Genitourinary (GU) Cancers Symposium

A Phase 3 study of gedatolisib plus fulvestrant with and without palbociclib in patients with HR+/HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor plus a non-steroidal aromatase inhibitor (VIKTORIA-1)

Sara Hurvitz, Fabrice Andre, Massimo Cristofanilli, Giuseppe Curigliano, Antonio Giordano, Hyo Han, Miguel Martin, Barbara Pistilli, Hope Rugo, Robert Wesolowski, Samuel Suzuki, Sarah C. Mutka, Igor Gorbatchevsky, Sibylle Loibl

2022 San Antonio Breast Cancer Symposium (SABCS)

Updated results of a Phase 1b study of gedatolisib plus palbociclib and endocrine therapy in women with hormone receptor positive advanced breast cancer: Subgroup analysis by PIK3CA mutation status

Robert Wesolowski, Hope S. Rugo, Erica M. Stringer-Reasor, Hyo Han, Jennifer M. Specht, E. Claire Dees, Peter Kabos, Ulka Vaishampayan, Seth A. Wander, Janice Lu, Keerthi Gogineni, Alexander Spira, Anne F. Schott, Maysa Abu-Khalaf, Pratima Nayak, Brian F. Sullivan, Igor Gorbatchevsky, Rachel M. Layman

2022 San Antonio Breast Cancer Symposium (SABCS)

A Phase 1B open-label study of gedatolisib (PF-05212384) in combination with other anti-tumour agents for patients with advanced solid tumours and triple-negative breast cancer. British Journal of Cancer 2022

Giuseppe Curigliano, Geoffrey I. Shapiro, Rebecca S. Kristeleit, Albiruni R. Abdul Razak, Stephen Leong, Maria Alsina, Antonio Giordano, Karen A. Gelmon, Erica Stringer-Reasor, Ulka N. Vaishampayan, Mark Middleton, Anthony J. Olszanski, Hope S. Rugo, Kenneth A. Kern, Nuzhat Pathan, Rachelle Perea, Kristen J. Pierce, Sarah C. Mutka & Zev A. Wainberg

British Journal of Cancer

Functional signaling test identifies HER2 negative breast cancer patients who may benefit from c-Met and pan-HER combination therapy. Cell Communication and Signaling, 20:4, 2022

Ian A. MacNeil, Salmaan A. Khan, Adrish Sen, Sajjad M. Soltani, David J. Burns, Brian F. Sullivan & Lance G. Laing

CELSignia

Phase II study of trastuzumab biosimilar (Herzuma®) plus gedatolisib in patients with HER-2 positive metastatic breast cancer who progressed after 2 or more HER-2 directed chemotherapy: KM-10A (KCSG BR 18-13) interim analysis

Ju Won Kim, Hee Kyung Ahn, Jong Gwon Choi, Yee Soo Chae, Gyeong-Won Lee, KeonUk Park, Eunmi Lee, Sung Hoon Sim, Jee Hyun Kim, Yeon Hee Park, Miso Ki1, Jin Hyun Park, Jeong Eun Kim, Han Jo Kim, Mi Sun Ahn, So Yeon Oh, Min Hwan Kim, Su-Jin Koh, Kyoung Eun Lee, Myoung Joo Kang, Jae Ho Byun, Joo young Ha, Jung Hye Kwon, Joo Young Jung, Su Ee Lee, Inhae Park, and Kyong Hwa Park

2021 San Antonio Breast Cancer Symposium (SABCS)

Phase Ib expansion study of gedatolisib in combination with palbociclib and endocrine therapy in women with ER+ metastatic breast cancer

Rachel M. Layman, Robert Wesolowski, Hyo Han, Jennifer M. Specht, Erica M. Stringer-Reasor, E. Claire Dees, Peter Kabos, Ingrid A. Mayer, Ulka Vaishampayan, Janice Lu, Keerthi Gogineni, Aditya Bardia, Anne F. Schott, Maysa M. Abu-Khalaf, Doug Hawkins, Brian Sullivan, Igor Gorbatchevsky, Hope S. Rugo

2021 San Antonio Breast Cancer Symposium (SABCS)

Phase I dose-escalation study of the dual PI3K-mTORC1/2 inhibitor gedatolisib in combination with paclitaxel and carboplatin in patients with advanced solid tumors. Clin Cancer Res;27:5012–9, 2021

Ilaria Colombo, Sofia Genta, Federica Martorana, Monia Guidi, Milo Frattini, Eleftherios Pierre Samartzis, Simone Brandt, Sheila Gaggetta, Laura Moser, Mariarosa Pascale, Tatiana Terrot, Cristiana Sessa, and Anastasios Stathis

Clinical Cancer Research

A randomized phase II non-comparative study of PF-04691502 and gedatolisib (PF-05212384) in patients with recurrent endometrial cancer, Gynecologic Oncology 142, 62–69, 2016

Josep María del Campo, Michael Birrer, Craig Davis, Keiichi Fujiwara, Ashwin Gollerkeri, Martin Gore, Brett Houk, Susie Lau, Andres Poveda, Antonio González-Martín, Carolyn Muller, Kei Muro, Kristen Pierce, Mie Suzuki, Jennifer Vermette, Amit Oza

Gynecologic Oncology