HLB Group to Resubmit Riboceranib for FDA Approval Following Second Rejection
• HLB Group announced plans to resubmit its targeted anticancer drug riboceranib for FDA approval by May after receiving a second rejection due to manufacturing issues with partner Hangseo Pharmaceutical.
• Chairman Jin Yang-gon expressed confidence in a potential FDA decision as early as July, while also revealing plans to pursue European Medicines Agency (EMA) approval in parallel.
• HLB Group shares, which initially plummeted following the FDA rejection, rebounded significantly with HLB stock rising 11.40% as investors responded to the company's commitment to pursue approval.
RYBREVANT and LAZCLUZE Combination Shows Significant Survival Improvement in EGFR-Mutated NSCLC
• Johnson & Johnson's RYBREVANT plus LAZCLUZE demonstrates statistically significant and clinically meaningful improvement in overall survival (OS) versus osimertinib in EGFR-mutated NSCLC.
• The MARIPOSA Phase 3 study showed the chemotherapy-free combination is expected to improve median OS by over one year compared to the current standard of care.
• RYBREVANT plus LAZCLUZE is approved in the U.S. and Europe as a first-line therapy for NSCLC patients with EGFR exon 19 deletions or L858R substitution mutations.
• The safety profile of the combination was consistent with individual treatments, with venous thromboembolic events managed through prophylactic anticoagulants.
Yuhan's Lung Cancer Drug Leclaza Secures European Approval in Combination Therapy
• Yuhan Corporation's third-generation EGFR-TKI lazertinib (Leclaza) has received European Commission approval in combination with J&J's Rybrevant for first-line treatment of EGFR-mutated non-small cell lung cancer.
• The Phase 3 MARIPOSA study demonstrated the combination therapy reduced disease progression risk by 30% compared to osimertinib, with median progression-free survival of 23.7 months versus 16.6 months.
• This milestone marks the first Korean anticancer drug approved in both the U.S. and Europe, triggering a $30 million payment to Yuhan as part of their $1.255 billion licensing deal with Johnson & Johnson.
EC Approves Amivantamab Plus Lazertinib for First-Line EGFR-Mutated NSCLC
• The European Commission has approved amivantamab plus lazertinib for first-line treatment of EGFR-mutated non-small cell lung cancer (NSCLC).
• The approval is based on the Phase 3 MARIPOSA trial, which showed superior progression-free survival compared to osimertinib.
• The combination therapy reduced the risk of disease progression or death by 30% compared to osimertinib monotherapy.
• Common adverse events were manageable and primarily Grade 1 or 2, supporting the combination's safety profile.
CHMP Recommends Subcutaneous Amivantamab for EGFR-Mutated NSCLC Treatment
• The CHMP has recommended subcutaneous amivantamab with lazertinib for first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
• Subcutaneous amivantamab monotherapy is recommended for NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.
• PALOMA-3 study results support the recommendation, showing non-inferior pharmacokinetics and a five-fold reduction in infusion-related reactions compared to IV administration.
• The subcutaneous formulation reduces administration time to approximately five minutes, offering improved convenience and safety for patients.
Urticaria Clinical Trial Pipeline Heats Up with Novel Therapies in Development
• The urticaria treatment landscape is evolving, with over 20 companies developing more than 25 novel therapies to address unmet patient needs.
• Regeneron and Sanofi's Dupixent demonstrated positive Phase III results for chronic spontaneous urticaria, showing promise for biologic-naive patients.
• Evommune initiated a Phase II trial of EVO756 for chronic inducible urticaria, while Celldex Therapeutics reported positive Phase II data for barzolvolimab in chronic spontaneous urticaria.
• Emerging therapies target various mechanisms, including IgE, mast cells, and kinases, offering diverse approaches to urticaria management.
RYBREVANT® Plus Chemotherapy Shows Positive Overall Survival Trend in EGFR-Mutated Lung Cancer
• Updated results from the Phase 3 MARIPOSA-2 study reveal that RYBREVANT® (amivantamab) combined with chemotherapy demonstrates consistent benefits in post-progression outcomes for patients with EGFR-mutated NSCLC.
• The combination therapy shows a favorable trend toward improved overall survival compared to chemotherapy alone, suggesting a potential shift in the treatment landscape for this patient population.
• Amivantamab plus chemotherapy significantly improves treatment discontinuation rates, with nearly five times as many patients remaining on therapy at 18 months compared to chemotherapy alone.
• Patients treated with the amivantamab combination experienced a 27 percent reduction in the risk of symptomatic progression, highlighting the potential for more durable treatment options.
Leclaza Monotherapy Shows Promise in EGFR-Mutated NSCLC
• Leclaza (lazertinib) monotherapy demonstrated a progression-free survival (PFS) of 18.5 months, surpassing Tagrisso's (osimertinib) 16.6 months in EGFR-mutated NSCLC.
• The objective response rate (ORR) for Leclaza monotherapy was 83%, comparable to Tagrisso's 85%, indicating similar tumor shrinkage efficacy.
• In patients with brain metastasis, Leclaza showed a PFS of 16.4 months, longer than Tagrisso's 13 months, suggesting potential benefits in this high-risk group.
• Yuhan Corporation is in discussions with Johnson & Johnson regarding potential FDA approval for Leclaza monotherapy, aiming for a broader application.
RYBREVANT Plus Chemotherapy Shows Positive Survival Trend in EGFR-Mutated Lung Cancer
• Updated results from the Phase 3 MARIPOSA-2 study show RYBREVANT plus chemotherapy demonstrates a favorable trend toward improved overall survival.
• At 18 months, 50% of patients treated with the combination were alive, compared to 40% receiving chemotherapy alone.
• The combination significantly improved treatment discontinuation rates and prolonged time to subsequent therapy.
• The safety profile of RYBREVANT plus chemotherapy was consistent with established profiles of individual treatments.
J&J Highlights Solid Tumor Advances at WCLC and ESMO 2024
• Johnson & Johnson is set to present 11 oral presentations at WCLC and ESMO 2024, showcasing advancements in solid tumor treatments for lung, bladder, prostate, and colorectal cancers.
• Phase 3 MARIPOSA study data will highlight RYBREVANT® plus LAZCLUZE™ as a first-line treatment for EGFR-mutated advanced NSCLC, demonstrating improved overall survival compared to osimertinib.
• New data from the SunRISe program will reveal the potential of TAR-200 as an organ-sparing therapy for bladder cancer, offering a novel targeted drug-releasing system.
• The OrigAMI-1 study will present initial results of RYBREVANT® plus chemotherapy in metastatic colorectal cancer, addressing the urgent need for more durable therapies.
FDA Approves Lazertinib Plus Amivantamab for First-Line EGFR-Mutated NSCLC
• The FDA has approved lazertinib (LECLAZA) in combination with amivantamab (RYBREVANT) as a first-line treatment for NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
• The approval was based on the Phase 3 MARIPOSA study, which demonstrated a 30% reduction in the risk of disease progression or death compared to osimertinib.
• The combination therapy showed a median progression-free survival of 23.7 months versus 16.6 months with osimertinib, and a longer duration of response (25.8 months vs. 16.8 months).
• This marks the first FDA approval of a Korea-born anticancer drug and represents a significant milestone for Yuhan Corporation's R&D investments.
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