DelveInsight’s, “HER2-Negative Breast Cancer Pipeline Insight 2024” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in HER2-Negative Breast Cancer pipeline landscape. It covers the HER2-Negative Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the HER2-Negative Breast Cancer Pipeline Report
- In October 2024:- Seagen Inc.- This clinical trial is to evaluate disitamab vedotin alone and in combination with tucatinib in subjects with LA/metastatic breast cancer or gastric cancer/GEJC that express HER2. The study has a dose escalation phase evaluating disitamab vedotin plus tucatinib followed by a dose optimization phase. The 2 dose levels identified in the dose escalation phase will be assessed in the optimization phase for both safety and efficacy in HER2-low LA/mBC subjects.
- In October 2024:- Novartis Pharmaceuticals- The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab.
- In October 2024:- Puma Biotechnology Inc.- PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
- In October 2024:- Processa Pharmaceuticals- This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.
- In October 2024:- Olema Pharmaceuticals Inc.- This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
- In October 2024:- AstraZeneca- A Phase IIIb Single Arm, 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib+ Fulvestrant as Treatment for Locally Advanced(Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients
- In October 2024:- Pfizer- The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
- In October 2024:- Hoffmann-La Roche- This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
- DelveInsight’s HER2-Negative Breast Cancer pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for HER2-Negative Breast Cancer treatment.
- The leading HER2-Negative Breast Cancer Companies such as Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs, and others.
- Promising HER2 Negative Breast Cancer Therapies such as Doxorubicin, Cyclophosphamide, Utidelone Combined with Bevacizumab, Capecitabine, Carboplatin, Cisplatin, and others.
Stay informed about the cutting-edge advancements in HER2-Negative Breast Cancer Treatments. Download for updates and be a part of the revolution in cancer care @ HER2-Negative Breast Cancer Clinical Trials Assessment
HER2-Negative Breast Cancer Emerging Drugs
- Giredestrant : Genentech
Giredestrant is a novel investigative small molecule that works as selective estrogen receptor degrader (SERD) by targeting the estrogen receptor (ER). The drug candidate is a new molecular entity (NME) which is administered through oral route. Preclinical studies suggest that Giredestrant is orally bioavailable and competitively inhibits the binding of estrogen to the ER. In preclinical models, Giredestrant has been shown to restrain the normally dynamic behavior of both wild-type and mutant ER, immobilizing the ER and attenuating the expression of its target genes. Currently, the drug is in Phase III stage of its development for the treatment of HER2 negative breast cancer.
- Inavolisib : Genentech
Inavolisib is an investigational small molecule designed to selectively inhibit mutant PI3Kα. In preclinical models, the molecule showed potent selective inhibition of PI3Kα and has increased potency to mutant PI3K cells over wild type. It is less sensitive for the other three PI3K isoforms. Inavolisib binds to the ATP-binding site of PI3Kα, thereby blocking phosphorylation of PIP2 to PIP3 and preventing downstream signaling as shown in preclinical models. Moreover, inavolisib specifically degrades the mutant form of PI3Kα, resulting in reduction of pathway activity. Currently the drug is in Phase III stage of its development for the treatment of HER2 negative breast cancer.
- CX-2009 : CytomX Therapeutics
CX-2009 (Praluzatamab ravtansine) is a conditionally activated antibody-drug conjugate (ADC) comprised of a CD166-directed humanized monoclonal antibody conjugated to the maytansinoid DM4, a tubulin inhibitor. Praluzatamab ravtansine utilizes CytomX Probody® platform technology, which incorporates a masking peptide to cover and block the cellular binding region of the antibody. Tethered to the antibody via a protease-cleavable linker, currently, the drug is in Phase II stage of its development for the treatment of HER2 negative breast cancer.
- H3B 6545 : H3 Biomedicine
H3B-6545 is an oral, selective estrogen receptor covalent antagonist (SERCA) for the research of metastatic ER-positive, HER2-negative breast cancer. H3B- 6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα.4 H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies. Currently, the drug is in Phase II stage of its development for the treatment of HER2 negative breast cancer.
- RGT-419B : Regor Therapeutics
RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. Results from non-clinical studies showed that RGT-419B demonstrated full suppression of ER+ breast cancer cell proliferation with acquired resistance to CDK4/6 inhibitors. Additionally, RGT-419B's tumor cell suppression was further augmented when combined with a selective estrogen receptor down-regulator or a PI3K signaling pathway inhibitor. Currently, the drug is in Phase I stage of its development for the treatment of HER2 negative breast cancer.
Learn more about HER2-Negative Breast Cancer Drugs opportunities in our groundbreaking Hepatic Tumor Research and development projects @ HER2-Negative Breast Cancer Unmet Needs
HER2-Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration
- Oral
- Parenteral
- Intravitreal
- Subretinal
- Topical
HER2-Negative Breast Cancer Products have been categorized under various Molecule types such as
- Monoclonal Antibody
- Peptides
- Polymer
- Small molecule
- Gene therapy
Discover the latest advancements in HER2-Negative Breast Cancer Treatment by visiting our website. Stay informed about how we're transforming the future of Oncology @ HER2-Negative Breast Cancer Market Drivers and Barriers, and Future Perspectives
Scope of the HER2-Negative Breast Cancer Pipeline Report
- Coverage- Global
- HER2-Negative Breast Cancer Companies- Genentech, CytomX Therapeutics, H3 Biomedicine, Regor Therapeutics, Immutep Limited, Merck & Co, Klus Pharma, Olema Pharmaceuticals, BeiGene, AstraZeneca, Janssen/Merck/GSK, Ono Pharmaceutical, Laekna Therapeutics, NanoMab, InSilico Medicine, TYK Medicine, Shanghai Pharmaceutical Group, Verastem Oncology, Allarity Therapeutics, Shenzhen Yangli Pharmaceutical Technology, Phoenix Molecular Designs, and others.
- HER2 Negative Breast Cancer Therapies- Doxorubicin, Cyclophosphamide, Utidelone Combined with Bevacizumab, Capecitabine, Carboplatin, Cisplatin, and others.
- HER2-Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- HER2-Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
For a detailed overview of our latest research findings and future plans, read the full details of H HER2-Negative Breast Cancer Pipeline on our website @ HER2-Negative Breast Cancer Drugs and Companies
Table of Content
- Introduction
- Executive Summary
- HER2 Negative Breast Cancer: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- HER2 Negative Breast Cancer– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Giredestrant : Genentech
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- CX-2009 : CytomX Therapeutics
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- RGT-419B : Regor Therapeutics
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug Name: Company Name
- Drug profiles in the detailed report…..
- Inactive Products
- HER2 Negative Breast Cancer Key Companies
- HER2 Negative Breast Cancer Key Products
- HER2 Negative Breast Cancer- Unmet Needs
- HER2 Negative Breast Cancer- Market Drivers and Barriers
- HER2 Negative Breast Cancer- Future Perspectives and Conclusion
- HER2 Negative Breast Cancer Analyst Views
- HER2 Negative Breast Cancer Key Companies
- Appendix
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