Abemaciclib

ROSALINE Trial: Neoadjuvant Letrozole/Entrectinib Shows Limited Efficacy in Invasive Lobular Breast Cancer

6 days ago

• The phase 2 ROSALINE trial found that combining entrectinib with letrozole failed to meet its primary endpoint, with no efficacy-evaluable patients achieving residual cancer burden (RCB) of 0 or 1 in invasive lobular breast cancer. • Despite the primary endpoint failure, the treatment showed a 49% objective response rate by MRI assessment, with 10% complete responses and 39% partial responses among the 41 evaluable patients. • ROSALINE represents the first neoadjuvant endocrine therapy trial dedicated exclusively to invasive lobular breast cancer, demonstrating the feasibility of subtype-specific trials while researchers continue biomarker analyses.

Breakthrough Breast Cancer Drug Capivasertib Approved for NHS Use

a month ago

• A groundbreaking twice-daily pill called capivasertib (Truqap) has been approved for NHS use, targeting hormone receptor-positive HER2-negative breast cancer by blocking cancer growth mechanisms. • Clinical trials demonstrated the drug extends time before cancer progression by over four months when used alongside hormone therapy Fulvestrant, offering new hope for approximately 3,000 women annually. • The treatment specifically benefits patients with PIK3CA, AKT1 or PTEN gene mutations, allowing many to maintain good quality of life with fewer debilitating side effects compared to other treatment regimens.

New Report Reveals Critical Insights into Clinical-Stage Pharma Partnerships from 2020-2025

2 months ago

• A comprehensive new industry report analyzes over 1,670 clinical-stage partnering agreements in pharma and biotech from 2020-2025, providing unprecedented access to deal structures and financial terms. • The report reveals detailed intelligence on how licensing agreements typically grant exclusive rights across Phase I-III trials, with multi-component structures involving collaborative R&D and commercialization strategies. • Business development professionals can now access actual contract documents and payment triggers often missing from press releases, enabling more effective negotiation strategies and competitive deal structuring.

Lerociclib Plus Fulvestrant Shows Promise in HR+/HER2- Advanced Breast Cancer

4 months ago

• The LEONARDA-1 phase 3 trial demonstrated that lerociclib plus fulvestrant significantly improved progression-free survival (PFS) compared to placebo plus fulvestrant in patients with HR+/HER2- advanced breast cancer. • The combination of lerociclib and fulvestrant showed a manageable safety profile, with hematological toxicities being the most common adverse events, effectively managed with dose adjustments. • Lerociclib plus fulvestrant exhibited efficacy across various patient subgroups, including those with primary endocrine therapy resistance and liver metastasis, addressing a critical unmet need. • The study supports lerociclib plus fulvestrant as a potential treatment option for patients with HR+/HER2- advanced breast cancer who have progressed on prior endocrine therapy.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Bayer's Elinzanetant Shows Promise in Reducing Hot Flashes for Breast Cancer Patients

4 months ago

• Elinzanetant met primary endpoints in the Phase III OASIS 4 trial, significantly reducing the frequency of moderate to severe vasomotor symptoms (VMS) in women undergoing endocrine therapy for breast cancer. • The study also achieved secondary endpoints, demonstrating a reduction in the severity of VMS, improvements in sleep disturbances, and enhanced menopause-related quality of life compared to placebo. • Elinzanetant is a dual neurokinin-1 and 3 receptor antagonist, representing a potential non-hormonal treatment option for VMS in breast cancer patients and women at high risk. • Bayer is advancing regulatory submissions for elinzanetant in the US, EU, and other global markets, with potential launch expected later this year, pending regulatory approvals.

FDA Expands Use of Verzenio in Early Breast Cancer Treatment

5 months ago

The FDA has approved Eli Lilly's Verzenio for a broader range of patients with early-stage breast cancer, removing the requirement for Ki-67 biomarker testing and extending its use to all adults with advanced breast cancer, including pre- and peri-menopausal women.

Datroway (Datopotamab Deruxtecan) Receives Global Approvals for Advanced Breast Cancer

5 months ago

• Datroway (Dato-DXd) gains first global approval in Japan for previously treated, unresectable, or recurrent HR-positive, HER2-negative breast cancer, offering a new alternative to conventional chemotherapy. • The FDA has approved Datroway for advanced breast cancer, marking the first U.S. approval for the antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo. • EMA endorsed Dato-DXd as a late-line option for certain breast cancer cases, adding to approvals in the U.S. and Japan and expanding treatment options in Europe. • Clinical trials, including TROPION-Breast01, demonstrated that Datroway significantly delayed cancer progression compared to standard chemotherapy, with manageable safety profiles.

Advancements in Breast Cancer Research Unveiled at SABCS 2024

5 months ago

• The PATINA trial suggests palbociclib with anti-HER2 and endocrine therapy may become a new standard for HR+, HER2+ metastatic breast cancer. • COMET trial indicates active monitoring is comparable to surgery for low-risk DCIS, offering a potential alternative management option. • OlympiA trial's long-term results reinforce olaparib's role in preventing recurrence and highlight the importance of BRCA testing for early-stage breast cancer.

Keytruda Approved in China for Early-Stage NSCLC Treatment

5 months ago

• Keytruda gains approval in China for resectable stage II, IIIA, or IIIB NSCLC in combination with platinum-containing chemotherapy. • The approval is based on the KEYNOTE-671 trial, demonstrating a significant improvement in overall survival and event-free survival. • This marks Keytruda's fourth indication for NSCLC in China, extending its use to earlier stages of the disease. • The treatment involves neoadjuvant Keytruda plus chemotherapy, followed by adjuvant Keytruda monotherapy post-surgery.

Imlunestrant Shows Promise in Advanced ER+/HER2- Breast Cancer Treatment

5 months ago

• Imlunestrant monotherapy significantly improved progression-free survival (PFS) in advanced breast cancer patients with ESR1 mutations compared to standard endocrine therapy. • The combination of imlunestrant and abemaciclib demonstrated a statistically significant improvement in PFS compared to imlunestrant alone, regardless of ESR1 mutation status. • The EMBER-3 trial results suggest imlunestrant, particularly in combination with abemaciclib, could offer a new all-oral targeted therapy option for pre-treated advanced breast cancer. • Safety data from the trial indicated that imlunestrant, both as a monotherapy and in combination, was generally well-tolerated, with manageable adverse events.

Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial

6 months ago

• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial. • The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users. • Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy. • The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.

Real-World Data Suggests Elacestrant Offers Similar or Improved Outcomes in Advanced Breast Cancer

6 months ago

• A real-world analysis shows elacestrant demonstrates similar or slightly higher time to treatment discontinuation compared to the EMERALD trial. • The median real-world time to next treatment with elacestrant was 6.43 months, and time to treatment discontinuation was 4.6 months. • Patients with PIK3CA pathway alterations experienced worse outcomes with elacestrant, underscoring the need for precision medicine. • Most patients received elacestrant beyond the second line of treatment, with outcomes remaining consistent across different lines of therapy.

Novartis' Kisqali Receives EC Approval for Early Breast Cancer Treatment

6 months ago

• The European Commission (EC) has approved Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor for adjuvant treatment of HR+/HER2- early breast cancer. • The approval is based on the Phase III NATALEE trial, demonstrating a 25.1% reduction in the risk of disease recurrence compared to endocrine therapy alone. • Kisqali is now approved for a broader population of early breast cancer patients in Europe, including those with node-negative disease at high risk of recurrence. • The decision follows positive recommendations and aligns with recent FDA approvals and NCCN guidelines, reinforcing Kisqali's role in early breast cancer treatment.

FDA Approvals of Ribociclib and Inavolisib Reshape HR+ Breast Cancer Treatment

6 months ago

• Ribociclib's approval for adjuvant use in high-risk HR+/HER2- early breast cancer marks a significant advancement, potentially benefiting a broader patient population. • Inavolisib, combined with palbociclib and fulvestrant, gains FDA approval for endocrine-resistant, PIK3CA-mutated HR+/HER2- advanced breast cancer, improving progression-free survival. • The FDA emphasizes the need for increased diversity in clinical trials and post-marketing studies to ensure the safety and efficacy of new drugs across all patient populations. • Dose optimization strategies, like those promoted by Project Optimus, are crucial for balancing efficacy and toxicity in novel targeted therapies for breast cancer.

Real-World Data Show No Overall Survival Difference Among First-Line CDK4/6 Inhibitors in HR+/HER2- Metastatic Breast Cancer

6 months ago

• A retrospective study of 9,146 patients revealed no significant difference in overall survival (OS) among palbociclib, ribociclib, and abemaciclib when combined with aromatase inhibitors as first-line treatment for HR+/HER2- metastatic breast cancer. • The P-VERIFY study used real-world data from electronic health records to compare the effectiveness of the three CDK4/6 inhibitor combinations, adjusting for potential confounders using standardized inverse probability of treatment weighting. • While progression-free survival benefits have been demonstrated for all three CDK4/6 inhibitors in phase 3 trials, this real-world analysis suggests that the statistically significant OS benefit observed with ribociclib may not translate to a significant difference in clinical practice. • The study acknowledges limitations such as smaller sample sizes and shorter follow-up for the ribociclib and abemaciclib cohorts, highlighting the need for longer-term data and further research to validate these findings.

CHMP Backs Novel Therapies: Onpattro for hATTR and Symkevi for Cystic Fibrosis

7 years ago

• The European Medicines Agency's CHMP has recommended approval for Alnylam's Onpattro (patisiran), a groundbreaking siRNA therapy for hereditary transthyretin-mediated amyloidosis with polyneuropathy. • Vertex's Symkevi (tezacaftor/ivacaftor), in combination with Kalydeco, received positive CHMP opinion for treating cystic fibrosis patients with specific F508del mutations. • The committee also endorsed several other medications, including Pierre Fabre's melanoma drugs and AstraZeneca's Imfinzi for lung cancer, while rejecting BMS's Opdivo-Yervoy combination for first-line kidney cancer.

Drug Development Updates