Tislelizumab

BeiGene to Present Extensive Hematology Data at EHA 2025, Showcasing BRUKINSA and Next-Generation Therapies

7 days ago

• BeiGene will present 31 abstracts at the European Hematology Association Congress in Milan, highlighting data from its BTK inhibitor BRUKINSA and investigational pipeline assets sonrotoclax and BGB-16673. • The company's next-generation pipeline assets have demonstrated promising clinical activity and safety profiles across multiple B-cell malignancies, with over 2,500 patients enrolled globally in clinical trials. • Four oral presentations will feature updated results from clinical studies of BGB-16673 in CLL/SLL and WM, as well as sonrotoclax in combination with BRUKINSA in R/R CLL/SLL and R/R MCL.

Summit Therapeutics' Ivonescimab Shows Promising Results in Phase 3 NSCLC Trial

19 days ago

• Summit Therapeutics reported statistically significant improvement in progression-free survival for ivonescimab plus chemotherapy versus BeiGene's Tevimbra combination in advanced squamous non-small cell lung cancer. • The bispecific antibody ivonescimab, licensed from Chinese biotech Akeso, is already approved in China but still undergoing multiple clinical trials globally for various cancer indications. • Despite mixed results against Merck's Keytruda in a separate NSCLC trial, ivonescimab's potential as a "pipeline in a drug" positions it for possible blockbuster status in the lucrative lung cancer market.

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.

BeiGene Discontinues Ociperlimab Development After Failed Phase III Lung Cancer Trial

2 months ago

• BeiGene has terminated development of its anti-TIGIT antibody ociperlimab following a futility analysis showing the drug was unlikely to meet overall survival endpoints in non-small cell lung cancer. • The decision comes after Novartis ended its $300 million licensing partnership with BeiGene in July 2023, forcing the biotech to reevaluate the drug's development pathway. • This setback adds to mounting challenges in the TIGIT inhibitor space, following Merck's recent discontinuation of two Phase III trials of its anti-TIGIT candidate vibostolimab due to safety and efficacy concerns.

Elahere Demonstrates Significant Survival Benefit in Phase III MIRASOL Trial for Platinum-Resistant Ovarian Cancer

2 months ago

• AbbVie's final analysis of the phase III MIRASOL trial confirms Elahere (mirvetuximab soravtansine) provides superior efficacy compared to chemotherapy in folate receptor alpha-positive platinum-resistant ovarian cancer patients. • Genmab's investigational antibody-drug conjugate rinatabart sesutecan showed promising results with a 55.6% objective response rate in heavily pre-treated ovarian cancer patients, regardless of FR𝛼 expression levels. • University of Pittsburgh researchers have identified a potential trigger for high-grade serous ovarian cancer: specific progenitor cells residing in fallopian tube supportive tissue.

Zimberelimab Plus Lenvatinib Shows Promise in Advanced Cervical Cancer After ICI Failure

2 months ago

• Phase 2 trial results demonstrate that zimberelimab combined with lenvatinib achieved a 33.3% objective response rate in patients with advanced cervical cancer who progressed after prior immune checkpoint inhibitor therapy. • The combination therapy demonstrated remarkable disease control, with 96.7% of patients experiencing stable disease or better, and a median progression-free survival of 7.1 months. • Treatment was well-tolerated with mostly mild to moderate adverse effects, with only 10% of patients experiencing grade 3/4 treatment-related adverse events.

FDA Tightens Requirements for China-Developed Drugs, Mandates Multi-Regional Trials

3 months ago

• The FDA has rejected multiple China-developed drugs, including Hutchmed's surufatinib and Eli Lilly's sintilimab, citing concerns over single-country clinical trial data. • At least 25 oncology drug applications from China face increased scrutiny, with the FDA emphasizing the need for multi-regional trials to ensure data generalizability across diverse populations. • The regulatory shift impacts China's growing biopharma sector, which has attracted significant Western partnerships, including Merck's recent $1.4 billion deal with Sichuan Kelun Pharmaceutical.

Chinese Cancer Drug Outperforms Merck's Keytruda in Landmark Lung Cancer Trial

3 months ago

• A novel Chinese experimental cancer drug has demonstrated unprecedented efficacy in late-stage trials, nearly doubling progression-free survival in non-small-cell lung cancer patients compared to Keytruda. • Merck's Keytruda, a leading cancer immunotherapy drug, has generated over $130 billion in sales since 2014, including $29.5 billion in the previous year. • The breakthrough Chinese trial results of 11.1 months versus Keytruda's 5.8 months mark a significant advancement in cancer immunotherapy and challenge Western pharmaceutical dominance.

Phase II Trial Shows Breakthrough 63.6% Response Rate for Novel Bladder Cancer Combination Therapy

3 months ago

• Disitamab Vedotin combined with Toripalimab achieved a 63.6% pathological complete response rate in muscle-invasive bladder cancer patients, nearly doubling traditional chemotherapy outcomes. • The clinical trial demonstrated strong efficacy across all HER2 expression levels, with HER2 IHC 3+ patients showing an exceptional 84.6% complete response rate. • The treatment showed favorable safety with only 27.7% grade 3 or higher adverse events, significantly lower than conventional chemotherapy's 40-50% rate.

EMA Recommends Approval for New Cancer Treatments and Vaccines

4 months ago

• The European Medicines Agency (EMA) has recommended eight new products for EU-wide approval, expanding treatment options for various conditions. • Several cancer treatments have received positive recommendations, potentially offering new hope for patients with different types of malignancies. • A new antiparasitic combination has been endorsed for use in non-EU markets, addressing a critical need in regions affected by parasitic infections. • The EMA is also reviewing new safety information regarding Leqembi, an Alzheimer's disease treatment, ensuring ongoing monitoring of its benefit-risk profile.

Akeso's Gumokimab (IL-17 mAb) Application Accepted for Psoriasis Treatment in China

4 months ago

• Akeso's gumokimab, an IL-17 targeting monoclonal antibody, has its NDA accepted by China's NMPA for treating moderate to severe plaque psoriasis. • Clinical trials showed gumokimab's rapid efficacy, with PASI 75 response rates approaching 96% at week 12 and sustained improvement over 52 weeks. • Safety profiles of gumokimab were comparable to placebo, indicating good tolerability, which addresses the need for safer psoriasis treatments. • Akeso aims to meet diverse patient needs by combining gumokimab with other drugs like ebronucimab, enhancing their autoimmune disease product synergy.

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.

J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

4 months ago

• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200. • TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC). • Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy. • The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.

FDA Sets PDUFA Date for Lower-Dose Neffy Nasal Spray in Young Pediatric Patients with Anaphylaxis

4 months ago

• The FDA has set a PDUFA target action date of March 6, 2025, for ARS Pharmaceuticals' sNDA for a 1 mg dose of Neffy (epinephrine nasal spray). • This lower dose is intended for pediatric patients weighing 33 to 66 lbs (15 to 30 kg), expanding treatment options for this vulnerable population. • Neffy was initially approved in August 2024 for anaphylaxis in adults and children over 66 lbs, offering a needle-free alternative to epinephrine injections. • Pending approval, Neffy 1 mg could be available in the second quarter of 2025, providing a more accessible and less intimidating treatment option for young children.

FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors

5 months ago

• The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab, for adult solid tumors previously approved for intravenous Opdivo. • CheckMate-67T trial data showed non-inferior pharmacokinetic exposures, similar efficacy, and comparable safety to intravenous Opdivo. • Opdivo Qvantig offers a faster 3-5 minute administration time, providing convenience and flexibility for patients. • The approval helps Bristol Myers Squibb maintain market share amid patent expirations and increasing biosimilar competition.

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.

Ivonescimab Demonstrates Superior PFS Over Pembrolizumab in PD-L1 Positive NSCLC

5 months ago

• Ivonescimab significantly improved progression-free survival (PFS) compared to pembrolizumab in patients with advanced NSCLC and PD-L1 TPS ≥ 1%. • The HARMONi-2 trial showed a hazard ratio of 0.51 (95% CI, 0.38-0.69; P < .0001) for PFS with ivonescimab versus pembrolizumab. • China's NMPA granted priority review to ivonescimab for first-line treatment of PD-L1 positive NSCLC, and the FDA granted fast track designation for EGFR-mutant NSCLC. • Ivonescimab, a PD-1/VEGF bispecific antibody, showed PFS benefits across PD-L1 expression subgroups and histological subtypes.

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.

BioNTech's Bispecific Antibody BNT-327 Shows Promise in Triple-Negative Breast Cancer

5 months ago

• BioNTech's BNT-327, a bispecific antibody targeting PD-L1 and VEGF, has demonstrated positive early results in patients with triple-negative breast cancer. • The bispecific antibody builds on the success of checkpoint inhibitors like Keytruda, potentially representing the next generation of immunotherapy drugs. • Early trial data, presented at the San Antonio Breast Cancer Symposium, suggest BNT-327 could become a critical component in treating triple-negative breast cancer. • The development of BNT-327 aligns with a broader interest in PD1/PD-L1 and anti-VEGF bispecifics, following promising results from Summit Therapeutics in lung cancer.

Drug Development Updates