While ASCO 2023 is just around the corner, The leading brands in the Pharma industry including AstraZeneca, Pfizer, Novartis, Sermonix, Daiichi Sankyo, etc. are all geared up for this conference to present the data readouts and final analysis. Breast Cancer is one of the most malignant forms of cancer affecting a large segment of the population in the US and the major countries in Europe. The key market players are quite enthusiastic about this indication for treatment. The hype for the session is the entry of KISQALI in early breast cancer and the detailed results ELAINE-2 study with longer patient follow-up for the treatment of ESR1-mutated ER+/HER2- metastatic breast cancer.
Breast Cancer Highlights
1. Abstract Number – LBA500
Title: Novartis to present the primary analysis of Phase III NATALEE trial of ribociclib + endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer
Main Content - NATALEE is the first and only positive Phase III study of a CDK4/6 inhibitor that has demonstrated consistent benefit in a broad population of patients with stage II and III HR+/HER2- early breast cancer (EBC) at risk of recurrence, including those with no nodal involvement.
Based on the analysis, it is also anticipated that the NATALEE study could also open up a big market to KISQALI, as Pfizer’s IBRANCE is out of the adjuvant game after two trial flops, and the market rivalry comes down to KISQALI and Eli Lilly’s VERZENIO, which boasts a first-in-class approval in high-risk patients.
Novartis is aiming for a bigger patient pool with KISQALI, one that consists of both high-risk and intermediate-risk individuals. VERZENIO is limited to treating people with lymph node-specific cancer, whereas Novartis also targets node-negative patients. According to Novartis, the NATALEE population would include a patient population that is two to three times bigger than the one currently covered by the VERZENIO label. Let’s wait for the complete set of data expected to be presented during the conference.
Abstract Number - 1057
Title - Sermonix Pharmaceutical’s Lasofoxifene, a potent oral SERM could play a critical role in the targeted precision medicine treatment of ESR1-mutated ER+/HER2- metastatic breast cancer (ELAINE 2 study update)
Main Content - We have heard a lot about SERDs, but we also have a selective estrogen receptor modulator (SERM) that can effectively target ESR1 mutants.The only SERM for the treatment of ESR1-mutated ER+/HER2- metastatic breast cancer in the second-line setting is lasofoxifene. Earlier in December 2022, at SABCS 2022, the drug had presented astonishing results as monotherapy and combination therapy (with abemaciclib) in the ELAINE 1 and ELAINE 2 study. With patient follow-up through Jan. 31, 2023, the combination of lasofoxifene and abemaciclib continued to be well-tolerated, with clinically meaningful efficacy in women with ER+/HER- metastatic breast cancer and an ESR1 mutation.
Now the company has planned to announce the detailed results of ELAINE-2 study with longer patient follow-up. Let’s wait for the full set of data to be announced during the conference.
Company |
Drug |
Trial Acronym |
Phase |
Abstract No. |
Abstract Title |
Novartis |
KISQALI |
NATALEE |
III |
#LBA500 |
Phase III NATALEE trial of ribociclib + endocrine therapy as adjuvant treatment in patients with HR+/HER22 early breast cancer |
Shanghai Junshi Biosciences |
Toripalimab |
TORCHLIGHT |
III |
#LBA1013 |
TORCHLIGHT: A randomized, double-blind, phase III trial of toripalimab versus placebo, in combination with nab-paclitaxel(nab-P) for patients with metastatic or recurrent TNBC |
Gilead Sciences |
TRODELVY |
TROPiCS-02 |
III |
#1003 |
Final Overall Survival (OS) Analysis from the Phase 3 TROPiCS-02 Study of Sacituzumab Govitecan (SG) in Patients (Pts) with Hormone Receptor–Positive/HER2-Negative (HR+/HER2–) Metastatic Breast Cancer (mBC) |
Genor Biopharma |
Lerociclib |
LEONARDA-1 |
III |
#1017 |
LEONARDA-1: Phase III randomized study of lerociclib plus fulvestrant in patients with HR+, HER2- locally advanced or metastatic breast cancer that has progressed on prior endocrine therapy |
Daiicho-Sanyko |
Patritumab Deruxtecan |
BRE 354 |
II |
#1004 |
A phase 2 study of HER3-DXd in patients with metastatic breast cancer |
AstraZeneca |
Camizestrant |
SERENA-2 |
II |
#1066 |
Clinical activity of camizestrant, a next-generation SERD, versus fulvestrant in patients with a detectable ESR1 mutation: Exploratory analysis of the SERENA-2 Phase 2 trial |
Sermonix Pharmaceuticals |
Lasofoxifene |
ELAINE 2 |
II |
#1057 |
Lasofoxifene (LAS) plus abemaciclib (Abema) for treating ESR1-mutated ER+/HER2- metastatic breast cancer (mBC) after progression on prior therapies: ELAINE 2 study update |
Oncolytics Biotech |
Pelareorep
|
BRACELET-1 |
II |
#1012 |
BRACELET-1 (PrE0113): Inducing an inflammatory phenotype in metastatic HR+/HER2- breast cancer with the oncolytic reovirus pelareorep in combination with paclitaxel and avelumab |
Pfizer |
PF-07220060 |
C4391001 |
I/IIa |
#3009 |
First-in-human first-in-class Phase 1/2a study of the next generation CDK4-selective inhibitor PF-07220060 in patients (pts) with advanced solid tumors, enriched for HR+ HER2- mBC pts who progressed on prior CDK4/6 inhibitors and endocrine therapy |
Pfizer |
PF-07104091 |
C4161001 |
I/IIa |
#3010 |
First-in-human Phase 1/2a study of a potent and novel CDK2-selective inhibitor PF-07104091 in patients (pts) with advanced solid tumors, enriched for CDK4/6 inhibitor resistant HR+/HER2- breast cancer pts |