Platinum

BeiGene Discontinues TIGIT Inhibitor Ociperlimab After Phase III Trial Failure Prediction

2 months ago

• BeiGene has halted development of its TIGIT inhibitor ociperlimab after predictive analyses indicated the Phase III clinical trial was unlikely to meet its primary endpoints. • This discontinuation adds to a growing list of TIGIT inhibitor failures in oncology, raising questions about the viability of this immunotherapy target pathway. • The decision represents a significant setback for BeiGene's immuno-oncology pipeline, though the company is expected to redirect resources to other promising candidates.

BioNTech's BNT327 Shows Promising 85% Response Rate in First-Line Treatment for Extensive-Stage SCLC

2 months ago

• BNT327, a bispecific antibody targeting both PD-L1 and VEGF-A, demonstrated an 85.4% confirmed response rate when combined with chemotherapy in extensive-stage small cell lung cancer patients. • The phase 2 trial showed impressive disease control in 97.9% of patients, with 12-month overall survival rates of 72.7%, suggesting potential improvement over current standard treatments. • Despite 86% of patients experiencing grade 3 or higher treatment-related adverse events, the safety profile was considered manageable with only 6% discontinuing treatment and no treatment-related deaths reported.

Merck's Subcutaneous Pembrolizumab Shows Comparable Efficacy to IV KEYTRUDA with Significantly Reduced Administration Time

2 months ago

• Merck's subcutaneous pembrolizumab with berahyaluronidase alfa demonstrated noninferior pharmacokinetics compared to intravenous KEYTRUDA in a pivotal Phase 3 trial for metastatic non-small cell lung cancer treatment. • The subcutaneous formulation, administered in approximately two minutes versus standard IV infusion, reduced patient chair time by nearly 50% and healthcare professional active time by 45.7%, potentially improving treatment efficiency. • FDA review of the subcutaneous pembrolizumab application is underway with a target action date of September 23, 2025, which could make it the first subcutaneous checkpoint inhibitor available across all KEYTRUDA's approved solid tumor indications.

FDA Signals Potential Traditional Approval Pathway for Genelux's Olvi-Vec in Platinum-Resistant Ovarian Cancer

2 months ago

• FDA indicates that Genelux's ongoing Phase 3 OnPrime/GOG-3076 trial could potentially support traditional approval for Olvi-Vec in platinum-resistant/refractory ovarian cancer without requiring a separate confirmatory study. • The regulatory guidance represents a significant milestone for Genelux, potentially accelerating the approval timeline if the trial demonstrates clinically meaningful progression-free survival advantage without compromising overall survival. • Topline safety and efficacy data from the registrational trial are expected in the first half of 2026, addressing an urgent unmet need for innovative treatments in this difficult-to-treat patient population.

PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial

3 months ago

• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months. • The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk. • Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.

Nivolumab Plus Ipilimumab Shows Promise in Advanced Hepatocellular Carcinoma

4 months ago

• The combination of nivolumab and ipilimumab has shown significantly improved overall survival in patients with unresectable hepatocellular carcinoma (HCC). • The CheckMate 9DW trial demonstrated a median overall survival of 23.7 months with nivolumab/ipilimumab compared to 20.6 months with lenvatinib or sorafenib. • The combination therapy also resulted in a higher objective response rate of 36% versus 13% with lenvatinib/sorafenib, indicating better tumor control. • The FDA has accepted the application for nivolumab plus ipilimumab as a first-line treatment for unresectable HCC, with a decision expected by April 2025.

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.

Anlotinib Maintenance Therapy Shows Promise in Extensive-Stage Small Cell Lung Cancer

4 months ago

• A retrospective study indicates that anlotinib maintenance therapy, particularly when combined with immunotherapy, significantly improves progression-free survival (PFS) and overall survival (OS) in ES-SCLC patients. • The median PFS was 7.2 months for all patients, and the median OS reached 17.6 months, highlighting the potential of anlotinib in prolonging survival in this aggressive cancer. • Combining anlotinib with immunotherapy resulted in a median PFS of 8.2 months and a median OS of 20.1 months, demonstrating a statistically significant improvement compared to anlotinib with chemotherapy. • The study confirms that anlotinib-related adverse events are manageable, with no unexpected toxicities or treatment-related deaths, supporting its safety profile in ES-SCLC maintenance therapy.

Patient-Derived Organoids Show Promise in Predicting Chemotherapy Response for Esophageal Cancer

5 months ago

A groundbreaking study demonstrates that patient-derived organoids (PDOs) can accurately predict chemotherapy responses in esophageal squamous cell carcinoma (ESCC) patients with 83.33% accuracy. The research, involving 55 patient samples, establishes PDOs as a potential tool for personalizing cancer treatment strategies.

FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma

5 months ago

• The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1. • In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death. • This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.

Camrelizumab and Apatinib Show Promise in Neoadjuvant Treatment of TNBC

5 months ago

• Camrelizumab plus chemotherapy significantly improved pathologic complete response (pCR) rates in early or locally advanced triple-negative breast cancer (TNBC). • Apatinib combined with sintilimab and chemotherapy demonstrated a high pCR rate of 70.6% in early TNBC, suggesting synergistic effects. • Both camrelizumab and apatinib regimens exhibited manageable safety profiles, supporting their potential as new neoadjuvant therapeutic options. • Biomarker analysis in the apatinib study identified correlations between immune response and pCR, offering insights for predicting treatment efficacy.

PD-L1 Expression Thresholds in Gastrointestinal Cancers Under Scrutiny for PD-1 Inhibitor Efficacy

6 months ago

• Experts debate optimal PD-L1 expression cutoffs for PD-1 inhibitor use in gastric, GEJ, and ESCC cancers, citing challenges in accurate PD-L1 scoring. • ODAC meetings highlight concerns about the risk-benefit profile of PD-1 inhibitors in patients with PD-L1-negative gastrointestinal tumors. • Tislelizumab's pending approval for ESCC shows greater survival benefit in patients with PD-L1 TAP scores of 10% or higher. • FDA approved zolbetuximab for HER2-negative gastric/GEJ adenocarcinoma with CLDN18.2 positivity, adding complexity to treatment paradigms.

FDA Approves Tevimbra Plus Chemotherapy for First-Line Treatment of Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA has approved Tevimbra (tislelizumab-jsgr) in combination with chemotherapy for first-line treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression. • The approval was based on the RATIONALE-305 trial, which showed a median overall survival of 15.0 months with Tevimbra plus chemotherapy compared to 12.9 months with chemotherapy alone. • Common side effects of Tevimbra in combination with chemotherapy include decreased blood cell counts, fatigue, and gastrointestinal issues, but the combination offers a manageable safety profile. • This approval marks the second for Tevimbra in 2024, highlighting its potential to address critical needs in oncology and providing a valuable new treatment option.

FDA Approves Zolbetuximab for CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA approved zolbetuximab in combination with chemotherapy for HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma on October 18, 2024. • Approval was based on the SPOTLIGHT and GLOW phase 3 trials, which demonstrated improved progression-free and overall survival with zolbetuximab plus chemotherapy. • Zolbetuximab targets CLDN18.2, a protein overexpressed in 50-80% of gastric cancers, offering a new targeted therapy option for previously non-targetable disease. • Routine CLDN18.2 testing is now crucial to identify patients who can benefit from zolbetuximab, establishing it as a standard of care in the first-line setting.

Subcutaneous Pembrolizumab Meets Primary Endpoints in Phase 3 NSCLC Trial

6 months ago

• Merck's subcutaneous pembrolizumab, co-administered with berahyaluronidase alfa, met its dual primary pharmacokinetic endpoints in a Phase 3 trial for metastatic NSCLC. • The trial compared subcutaneous pembrolizumab plus chemotherapy to intravenous KEYTRUDA plus chemotherapy as a first-line treatment. • Secondary endpoints of efficacy and safety were generally consistent between the subcutaneous and intravenous pembrolizumab groups. • Subcutaneous pembrolizumab, administered in approximately 2-3 minutes, may improve patient experience and increase access compared to intravenous administration.

FDA Approves Zolbetuximab for CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA approved zolbetuximab in combination with chemotherapy for first-line treatment of locally advanced, unresectable, or metastatic HER2-negative gastric or GEJ adenocarcinoma. • Approval was based on the SPOTLIGHT and GLOW trials, which demonstrated improved survival with the addition of zolbetuximab to standard chemotherapy regimens. • Zolbetuximab targets CLDN 18.2, a protein involved in cell adhesion, offering a novel approach for managing this challenging cancer type. • Biomarker testing for CLDN 18.2 is now crucial for guiding treatment strategies and improving outcomes in gastric and GEJ adenocarcinoma.

EMA Committee Recommends Keytruda Plus Chemotherapy for Non-Epithelioid Mesothelioma

6 months ago

• The EMA's CHMP has recommended Keytruda in combination with pemetrexed and platinum chemotherapy for first-line treatment of unresectable non-epithelioid malignant pleural mesothelioma (MPM). • The recommendation is based on the Phase 2/3 KEYNOTE-483 trial, which demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone. • In the KEYNOTE-483 trial, Keytruda plus chemotherapy reduced the risk of death by 21% (HR=0.79) and significantly improved progression-free survival (PFS) versus chemotherapy alone. • The European Commission will now review the CHMP's recommendation, with a final decision expected in Q4 2024, potentially offering a new treatment option for this difficult-to-treat cancer.

FDA Grants Priority Review to Belzutifan for Advanced Pheochromocytoma and Paraganglioma

6 months ago

• The FDA has granted priority review to belzutifan (Welireg) for treating advanced pheochromocytoma and paraganglioma (PPGL) in adult and pediatric patients. • The sNDA is based on positive objective response rate (ORR) and duration of response (DOR) data from the Phase 2 LITESPARK-015 trial. • Belzutifan, a HIF-2α inhibitor, could become the first approved therapy for advanced PPGL in the U.S., addressing a significant unmet need. • The FDA's target action date is set for May 26, 2025, indicating an expedited review process for this potential new treatment option.

Zolbetuximab Plus Chemotherapy Improves Survival in CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• Zolbetuximab combined with chemotherapy significantly improves progression-free survival (PFS) and overall survival (OS) in patients with HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. • Pooled analysis of the SPOTLIGHT and GLOW trials demonstrated a median PFS of 9.2 months with zolbetuximab plus chemotherapy compared to 8.2 months with placebo plus chemotherapy. • The combination therapy also showed a median OS of 16.4 months versus 13.7 months in the placebo arm, with manageable gastrointestinal toxicities. • Zolbetuximab has received approval in Japan and Europe for CLDN18.2-positive gastric cancer and is awaiting approval in other regions.

Etoposide Shortage Linked to Worse Outcomes in Small Cell Lung Cancer

6 months ago

• A Canadian study revealed that a sustained etoposide shortage from 2018-2020 negatively impacted outcomes for patients with extensive-stage small cell lung cancer. • The shortage led to decreased progression-free survival and an increased rate of hospitalization among patients with ES-SCLC. • The findings underscore the critical need for reliable drug supplies in oncology to avoid detrimental effects on patient care and treatment efficacy.

Drug Development Updates