Gamehost Inc | MedPath

Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug

3 days ago

• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones. • SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year. • The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.

AACR Annual Meeting 2025 to Bridge Gap Between Cancer Science and Clinical Practice

a month ago

• The American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago will focus on "Unifying Cancer Science and Medicine" with presentations spanning from basic research to practice-changing clinical trials. • Program chairs Dr. Lillian Siu and Dr. Matthew Vander Heiden emphasize cross-disciplinary collaboration, encouraging attendees to explore topics outside their expertise to foster innovation in cancer research. • Key clinical trials to be presented include promising data on zongertinib for HER2-mutant lung cancer, dostarlimab for rectal cancer, and an off-the-shelf CAR NK cell therapy for hematologic malignancies.

Guardant Health and Pfizer Form Strategic Alliance to Advance Cancer Therapies Using Liquid Biopsy Technology

a month ago

• Guardant Health and Pfizer have established a multi-year collaboration to utilize Guardant's Infinity smart liquid biopsy platform in developing and commercializing Pfizer's oncology portfolio. • The partnership will evaluate circulating tumor DNA as a surrogate endpoint for monitoring therapy response and explore related blood-based epigenomic analyses in global clinical trials. • Pfizer gains access to Guardant's liquid biopsy tests in China through Guardant's existing partnership with Adicon Holdings, addressing a critical market where cancer is the leading cause of death with over three million cancer-related deaths in 2020.

Guardant Health's Shield Multi-Cancer Detection Test Shows Strong Performance Across 10 Cancer Types

a month ago

• Guardant Health's blood-based Shield Multi-Cancer Detection test demonstrated 98.5% specificity and 60% overall sensitivity across ten tumor types, with particularly strong results for aggressive cancers. • The test achieved 89% accuracy for cancer signal of origin prediction, potentially enabling clinicians to identify the primary tumor location through a simple blood draw. • Based on these promising results, the National Cancer Institute selected Shield MCD for its upcoming Vanguard Study evaluating emerging multi-cancer detection technologies.

CMS Grants ADLT Status to Guardant Health's Shield Blood Test for Colorectal Cancer Screening

2 months ago

• The Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for Guardant Health's Shield blood test, the first FDA-approved blood test for primary colorectal cancer screening. • Beginning April 1, 2025, Medicare will reimburse the Shield test at $1,495 during the initial nine-month ADLT period, representing a significant increase from the previous $920 reimbursement rate. • Analysts project the increased reimbursement could generate approximately $10 million in additional revenue for Guardant Health, beyond the company's projected $25-30 million in annual screening revenue.

KIYATEC Secures CAP Accreditation and NY State Approval for Revolutionary 3D Cancer Diagnostic Platform

3 months ago

• KIYATEC's laboratory has received prestigious College of American Pathologists (CAP) accreditation and New York State approval for its innovative 3D Predict cancer diagnostic test, validating its quality standards and clinical utility. • The company's proprietary 3D cell culture platform represents a breakthrough in functional precision oncology, offering the first evidence-based correlation between therapeutic response predictions and actual patient outcomes. • The 3D Predict platform brings new hope for high-grade glioma patients, including those with glioblastoma, by providing oncologists with patient-specific treatment response predictions to guide therapy decisions.

FDA Grants Priority Review to Boehringer's Zongertinib for HER2-Mutant Advanced Lung Cancer

3 months ago

• Boehringer Ingelheim's zongertinib could become the first oral targeted therapy for previously treated HER2-mutant advanced non-small cell lung cancer, with FDA decision expected in Q3 2025. • Phase Ib trial demonstrated impressive 71% objective response rate in 75 previously treated NSCLC patients, with favorable safety profile and low treatment discontinuation rate. • The drug addresses a significant unmet need in HER2-mutant NSCLC patients, who currently face poor prognosis with limited treatment options and less than 30% five-year survival rate.

Blood Test Shows Promise in Detecting Colon Cancer

4 months ago

• A new blood test demonstrated 81% accuracy in detecting colon cancer and 90% accuracy in ruling it out among healthy individuals, according to a recent study. • The study involved over 27,000 adults aged 45-85 who underwent blood tests followed by colonoscopies to screen for cancer. • Experts suggest the blood test could improve colorectal cancer screening rates, offering a convenient alternative to colonoscopies and stool-based tests. • While promising, experts caution that blood tests should not replace colonoscopies, which remain the gold standard for colon cancer screening and prevention.

FDA Approves Lumakras and Vectibix Combination for KRAS G12C-Mutated Metastatic Colorectal Cancer

4 months ago

• The FDA has approved Lumakras (sotorasib) combined with Vectibix (panitumumab) for treating KRAS G12C-mutated metastatic colorectal cancer in adults after prior chemotherapy. • CodeBreaK 300 trial data showed the combination significantly improved progression-free survival compared to standard of care in chemorefractory patients. • Patients on Lumakras and Vectibix had a median progression-free survival of 5.6 months, compared to 2 months on standard of care, with a 26% overall response rate. • This approval provides a new targeted treatment option for a subset of colorectal cancer patients with limited alternatives, emphasizing the importance of biomarker testing.

Pfizer's Sasanlimab Plus BCG Shows Promise in BCG-Naive, High-Risk NMIBC

4 months ago

• Pfizer's Phase 3 CREST trial showed that sasanlimab combined with BCG significantly improved event-free survival in BCG-naive, high-risk NMIBC patients. • The combination therapy demonstrated a clinically meaningful and statistically significant improvement compared to BCG alone in the study. • Sasanlimab's safety profile in combination with BCG was consistent with the known profiles of both agents, according to the trial data. • Pfizer plans to submit the CREST trial results for presentation at an upcoming medical congress and discuss potential regulatory filings.

Precision Medicine and Value-Based Cancer Care: Navigating Implementation Challenges in Academic and Community Settings

5 months ago

• Precision medicine adoption in oncology faces distinct challenges in academic and community settings, with issues ranging from workflow variations to bureaucratic constraints in implementing biomarker testing. • Texas Oncology's implementation of cloud-based technology has improved clinical trial matching and patient tracking, while a new state law mandates insurance coverage for NGS testing in metastatic solid tumors. • Multiple myeloma treatment has evolved to include quadruplet therapies and CAR T-cell therapy, with MRD testing emerging as a valuable tool for treatment decision-making and value-based care alignment.

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.

J&J's Carvykti Shows Promise in Earlier Myeloma Treatment

5 months ago

• The CARTITUDE-4 study indicates that Carvykti (ciltacabtagene autoleucel) significantly improves progression-free survival in multiple myeloma patients with 1-3 prior lines of therapy. • Carvykti, a BCMA-directed CAR-T therapy, may soon be used earlier in the treatment pathway, potentially leapfrogging Bristol-Myers Squibb's Abecma. • The study compared Carvykti to standard three-drug regimens, showing a significant benefit that led to unblinding of the trial. • Expansion of Carvykti's use is a key component of J&J's strategy in multiple myeloma, alongside other therapies like Darzalex and bispecific antibodies.

Global Lung Ambition Alliance Takes Aim at Three Major Challenges in Lung Cancer Care

5 years ago

• The Lung Ambition Alliance, a partnership of major healthcare organizations, aims to double five-year lung cancer survival rates by 2025 through improved screening, innovative medicines, and enhanced quality of care. • Current global statistics show only 20% of lung cancer patients survive five years post-diagnosis, with significant disparities between countries like Japan (30% survival) and other regions. • The Alliance is addressing key challenges through initiatives including cloud-based screening registry ELIC, the Major Pathologic Response Project for pre-operative therapy, and the ILC2 grant programme for patient organizations.