Capivasertib

AstraZeneca Discontinues Phase 3 Trial of Truqap for Metastatic Prostate Cancer

23 days ago

• AstraZeneca has halted the CAPItello-280 Phase 3 trial evaluating Truqap in combination with docetaxel and androgen-deprivation therapy for metastatic castration-resistant prostate cancer. • The decision followed an interim analysis by an independent data monitoring committee, which determined the treatment was unlikely to meet its dual primary endpoints of radiographic progression-free survival and overall survival. • Despite this setback, AstraZeneca will continue working with investigators to ensure proper patient follow-up and will use data from the trial to inform ongoing research in prostate cancer treatment.

AstraZeneca Halts Phase 3 Trial of Capivasertib for Metastatic Castration-Resistant Prostate Cancer

23 days ago

• AstraZeneca has discontinued the Phase 3 CAPItello-280 trial evaluating Truqap (capivasertib) plus docetaxel and ADT in metastatic castration-resistant prostate cancer after an independent monitoring committee determined the treatment was unlikely to meet primary endpoints. • The trial involved 1,033 patients and was designed to validate earlier promising results from the Phase 2 ProCAID trial, which had shown extended overall survival with capivasertib in patients who received prior androgen receptor-targeted therapy. • Despite the setback in prostate cancer, Truqap remains approved in multiple countries for HR-positive, HER2-negative locally advanced or metastatic breast cancer with specific biomarker alterations following progression on endocrine-based regimens.

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.

Alzheon to Present Phase 3 Data for ALZ-801, Aiming to Slow Alzheimer's Progression

4 months ago

• Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene. • Anavex Life Sciences has submitted blarcamesine for approval in Europe after completing Phase 2/3 trials, though its efficacy has faced criticism and legal challenges. • Athira Pharma discontinued fosgonimeton development after failing to demonstrate clinical benefit and settled with the DOJ over data manipulation allegations. • Eisai and Biogen's Leqembi may become more accessible with an injectable version under FDA review, potentially allowing for at-home administration.

Acalabrutinib Receives FDA Approval for Previously Untreated Mantle Cell Lymphoma

4 months ago

• The FDA has granted traditional approval to acalabrutinib in combination with bendamustine and rituximab for untreated MCL patients ineligible for stem cell transplant. • The approval was based on the ECHO trial, which showed a 27% reduction in disease progression or death compared to chemoimmunotherapy alone. • Median progression-free survival was 66.4 months with acalabrutinib versus 49.6 months with chemoimmunotherapy, demonstrating a clinically significant improvement. • Acalabrutinib is now the first and only BTK inhibitor approved for first-line MCL treatment, offering a new option for this rare and aggressive cancer.

Lilly to Acquire Scorpion Therapeutics' Mutant-Selective PI3Kα Inhibitor Program for $2.5 Billion

4 months ago

• Eli Lilly is set to acquire Scorpion Therapeutics' PI3Kα inhibitor program, including STX-478, currently in Phase I/II trials, for up to $2.5 billion. • STX-478 is a novel, oral, mutant-selective PI3Kα inhibitor targeting breast cancer and advanced solid tumors, potentially offering improved tolerability. • The acquisition expands Lilly's oncology pipeline, aiming to address the unmet need for effective and safe treatments for hormone-positive breast cancers with PI3Kα mutations. • Scorpion Therapeutics will spin out a new entity focusing on precision medicines, with Lilly retaining a minority equity interest in the new company.

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.

Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer

5 months ago

• The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression. • DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy. • Patients on Enhertu had a median progression-free survival of 13.2 months versus 8.1 months on chemotherapy. • This approval expands Enhertu's use to an earlier treatment setting and a broader patient population.

Truqap Offers New Hope for HR+/HER2- Breast Cancer Treatment in Korea

6 months ago

• Truqap (capivasertib), the first AKT inhibitor, is now available in Korea for HR+/HER2- locally advanced or metastatic breast cancer patients with PIK3CA, AKT1, and PTEN mutations. • Clinical trials demonstrated Truqap's efficacy in improving median progression-free survival (mPFS) by 7.3 months compared to fulvestrant monotherapy's 3.1 months in patients who failed first-line endocrine therapy. • Truqap has shown a 30% improvement in overall survival (OS) in clinical trials, offering a significant advantage for second-line treatment options. • Truqap's clinical trial enrolled a patient population more reflective of real-world scenarios, including those previously treated with CDK4/6 inhibitors, making the data more relevant for clinical application.

Truqap Plus Abiraterone Shows Promise in PTEN-Deficient Metastatic Prostate Cancer

6 months ago

• AstraZeneca's Truqap, combined with abiraterone and ADT, significantly improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer. • The Phase III CAPItello-281 trial demonstrated a clinically meaningful benefit compared to abiraterone and ADT with placebo in this specific patient population. • An early trend towards improved overall survival was observed, though data is still immature, with the trial continuing to assess this key secondary endpoint. • This combination marks the first AKT inhibitor to show benefit in this aggressive prostate cancer subtype, addressing a critical unmet need.

Roche to Acquire Poseida Therapeutics; Merck, AstraZeneca, and Novartis Report Pipeline Success

6 months ago

• Roche will acquire Poseida Therapeutics for $1.0 billion, expanding its CAR-T therapy portfolio, targeting hematological malignancies, solid tumors, and autoimmune diseases. • Merck's Winrevair phase III study met its primary endpoint, showing a statistically significant reduction in morbidity or mortality events in advanced pulmonary arterial hypertension. • AstraZeneca's Truqap, combined with Zytiga and ADT, significantly improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer. • Novartis received European Commission approval for Kisqali to treat HR+/HER2- early breast cancer patients at high risk of disease recurrence, based on the NATALEE phase III trial.

Drug Development Updates