Targeted Radiopharmaceuticals Summit Returns to Europe and US as Industry Momentum Builds
• The 6th Targeted Radiopharmaceuticals Summit Europe will take place in Amsterdam on December 3-5, featuring 40+ speakers across pre-clinical and clinical tracks as radiopharmaceutical innovation accelerates.
• Major pharmaceutical companies including Novartis, Eli Lilly, AstraZeneca, and Bayer are driving industry growth through billion-dollar collaborations and clinical advancements in novel radiopharmaceutical targets.
• The 4th Targeted Radiopharmaceuticals Summit US returns to San Diego in July, bringing together 275+ global stakeholders to address key challenges in isotope supply, manufacturing, and clinical translation.
AstraZeneca Halts Phase 3 Trial of Capivasertib for Metastatic Castration-Resistant Prostate Cancer
• 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 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.
Verastem Oncology to Present New LGSOC Treatment Data at SGO 2025 Annual Meeting
• Verastem Oncology will present additional analyses from the Phase 2 RAMP 201 trial evaluating avutometinib plus defactinib in recurrent low-grade serous ovarian cancer at SGO 2025, building on their FDA Priority Review submission.
• The presentations include new subgroup analyses by KRAS mutational status, supporting the company's ongoing efforts to advance treatment options for RAS/MAPK pathway-driven cancers.
• The company's NDA for the avutometinib-defactinib combination therapy has received Priority Review from the FDA with a PDUFA date of June 30, 2025, for KRAS mutant LGSOC patients.
Novel Blood Test Breakthrough Promises Less Invasive Monitoring for Childhood Cancer Treatment
• Scientists at the Institute of Cancer Research, London have developed a groundbreaking blood test using circulating tumor DNA (ctDNA) that provides comprehensive tracking of childhood cancer progression and treatment response.
• The SMPaeds1 study demonstrated that ctDNA testing can detect additional DNA mutations missed by traditional tumor biopsies, offering a less invasive alternative for monitoring pediatric cancers.
• This advancement, funded by Children With Cancer UK and Cancer Research UK, paves the way for more targeted treatments and improved understanding of cancer relapse mechanisms in young patients.
Alzheon to Present Phase 3 Data for ALZ-801, Aiming to Slow Alzheimer's Progression
• 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.
Kazia Therapeutics Launches Phase 1b Trial of Paxalisib with Immunotherapy for Advanced Breast Cancer
• Kazia Therapeutics has initiated the ABC-Pax trial to evaluate paxalisib combined with immunotherapy in advanced breast cancer patients.
• The Phase 1b study will assess the safety and efficacy of paxalisib with pembrolizumab or olaparib in triple-negative breast cancer.
• The trial utilizes a novel liquid biopsy platform for real-time monitoring of cancer and immune cell behavior during treatment.
• This combination aims to reprogram dormant cancer cells, making them susceptible to immune attack, potentially improving patient outcomes.
MRI Scans Significantly Reduce Time to Treatment for Aggressive Bladder Cancer
• A new study reveals that using MRI scans for initial diagnosis of muscle-invasive bladder cancer can reduce the time to treatment by over six weeks.
• The research found that patients receiving MRI scans had a median wait time of 53 days compared to 98 days with the standard surgical procedure.
• MRI scans can also help some patients avoid unnecessary surgical procedures, potentially saving costs and freeing up surgical resources.
• The study suggests that incorporating MRI into the diagnostic pathway could lead to faster treatment and improved outcomes for bladder cancer patients.
ZEST Trial Halted Due to Low ctDNA Detection Rates in Early Breast Cancer
• The Phase III ZEST trial, evaluating niraparib for preventing breast cancer recurrence based on circulating tumor DNA (ctDNA), was terminated early due to low ctDNA detection rates.
• Broad entry criteria in ZEST led to the inclusion of low-risk patients, resulting in a low rate of ctDNA positivity and hindering the trial's randomization process.
• Exploratory analysis suggested a longer recurrence-free interval with niraparib in patients with low ctDNA levels at baseline, though the study was underpowered.
• Future ctDNA-guided trials should focus on higher-risk patients and earlier ctDNA testing during neoadjuvant therapy to improve feasibility and outcomes.
Olaparib Shows Sustained Benefit in Early-Stage BRCA-Mutated Breast Cancer
• Olaparib improves long-term survival in women with high-risk, early-stage breast cancer and BRCA1/2 mutations, reducing cancer recurrence risk by 35%.
• After six years, 87.5% of olaparib-treated patients were alive, compared to 83.2% in the placebo group, demonstrating a significant survival advantage.
• The OlympiA trial reinforces the importance of BRCA testing to identify patients who can benefit from personalized olaparib treatment early.
• Olaparib is now recommended by NICE in England and Wales for early-stage, high-risk breast cancer with BRCA1/2 mutations, improving survival chances.
Truqap Plus Abiraterone Shows Promise in PTEN-Deficient Metastatic Prostate Cancer
• 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.
Truqap plus Abiraterone and ADT Improves rPFS in PTEN-Deficient Metastatic Hormone-Sensitive Prostate Cancer
• The CAPItello-281 Phase III trial evaluated Truqap in combination with abiraterone and ADT for metastatic hormone-sensitive prostate cancer (mHSPC) with PTEN deficiency.
• Results showed a statistically significant improvement in radiographic progression-free survival (rPFS) compared to abiraterone and ADT alone in this patient population.
• The safety profile of Truqap in combination with abiraterone and ADT was consistent with the known profiles of each medicine.
• AstraZeneca plans to present the data at an upcoming medical meeting and share it with global regulatory authorities.
Triple-Drug Combination Shows Promise in HR+/HER2- Breast Cancer Treatment
• A novel triple-drug combination significantly extends progression-free survival in patients with HR+/HER2- breast cancer, offering a potential new treatment approach.
• The combination of palbociclib, inavolisib, and fulvestrant demonstrated a median progression-free survival of 15 months, compared to 7.3 months with palbociclib and fulvestrant alone.
• The study results indicate that the triple-drug regimen could prevent cancer from developing resistance to therapy, representing a transformative advance.
• The innovative treatment provides renewed hope for patients battling HR+/HER2- breast cancer, particularly those with PIK3CA gene mutations.
Inavolisib Combination Significantly Improves Progression-Free Survival in PIK3CA-Mutated Breast Cancer
• A novel three-drug combination including inavolisib, palbociclib, and fulvestrant significantly extended progression-free survival in patients with PIK3CA-mutated, HR+/HER2- breast cancer.
• Patients receiving the combination therapy experienced a median progression-free survival of 15 months, compared to 7.3 months in the placebo group.
• After 18 months, 46.2% of patients on the three-drug regimen showed no disease progression, versus 21.1% in the placebo group.
• The new combination therapy helps prevent resistance to therapy, offering a potentially transformative advance for individuals with this specific type of breast cancer.
Inavolisib Triple Therapy Doubles Progression-Free Survival in PIK3CA-Mutated Breast Cancer
• A novel three-drug combination of inavolisib, palbociclib, and fulvestrant significantly extends progression-free survival in patients with PIK3CA-mutated, HR+/HER2- advanced breast cancer.
• The INAVO120 trial demonstrated that the triple therapy delayed disease progression by an average of 15 months compared to 7.3 months with palbociclib and fulvestrant plus placebo.
• After 18 months, 46.2% of patients on the inavolisib combination showed no disease progression, versus 21.1% in the placebo group, marking a potential 'transformative advance'.
• The FDA has already approved the three-drug regimen, and researchers anticipate it becoming a standard of care pending licensing in other regions.
Inavolisib Triple Therapy Doubles Progression-Free Survival in Advanced Breast Cancer
• A novel three-drug regimen including inavolisib significantly extends progression-free survival in patients with PIK3CA-mutated, HR+/HER2- advanced breast cancer.
• The combination therapy delayed disease progression by 15 months, compared to 7.3 months with the standard palbociclib and fulvestrant treatment.
• After 18 months, nearly twice as many patients on the triple-drug therapy showed no disease progression compared to the standard treatment group.
• Researchers suggest this breakthrough could transform treatment for a common, aggressive form of breast cancer.
Nivolumab Plus Chemotherapy Significantly Improves Cure Rate in Common Breast Cancer
• A clinical trial reveals that adding nivolumab to chemotherapy before surgery significantly improves outcomes for ER+/HER2- breast cancer patients.
• The study showed a pathological complete response (pCR) rate of 25% in patients treated with nivolumab plus chemotherapy, compared to 14% in the placebo group.
• Patients with tumors expressing the PD-L1 biomarker showed an even higher pCR rate of 44% with nivolumab, suggesting a more pronounced treatment effect.
• The findings indicate a potential new treatment approach for the most common type of breast cancer, offering improved cure rates.
Inavolisib Combination Therapy Doubles Survival in Advanced Breast Cancer
• A novel three-drug combination, including inavolisib, has demonstrated a doubling of survival time in patients with advanced breast cancer compared to standard treatments.
• The international trial involved 325 patients, many with cancer spread to multiple organs, highlighting the potential of this regimen in challenging cases.
• The combination therapy includes inavolisib along with two drugs already available, potentially facilitating quicker adoption into clinical practice.
• Researchers from the Institute of Cancer Research (ICR) and the Royal Marsden NHS Foundation Trust led the study, marking a significant advancement in breast cancer treatment.
Inavolisib Combination Therapy Doubles Progression-Free Survival in Advanced Breast Cancer
• A three-drug combination of inavolisib, palbociclib, and fulvestrant significantly extends progression-free survival in patients with PIK3CA-mutated, HR-positive advanced breast cancer.
• The study, published in _The New England Journal of Medicine_, showed the combination therapy delayed disease progression by an average of 15 months compared to 7.3 months with placebo.
• After 18 months, 46.2% of patients on the three-drug therapy showed no disease progression, compared to 21.1% in the placebo group.
• The inavolisib combination, recently approved by the FDA, represents a potential transformative advance for a common and aggressive form of breast cancer.
Triple-Drug Therapy Doubles Survival Time in Advanced Breast Cancer with PIK3CA Mutation
• A novel three-drug combination significantly improves progression-free survival in HR-positive breast cancer patients with PIK3CA mutations.
• The therapy, combining inavolisib, palbociclib, and fulvestrant, targets key aspects of PIK3CA mutant HR-positive breast cancer biology.
• The palbociclib-fulvestrant combination has been available on the NHS for certain breast cancer patients since 2022.
• The FDA approved the three-drug therapy earlier this month, marking a potential transformative advance in treatment.
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