Cetrelimab

Immune Checkpoint Inhibitors Emerge as Standard of Care for Early-Stage NSCLC, New Data Shows

2 months ago

• Neoadjuvant, adjuvant, and perioperative PD-L1 immune checkpoint inhibitors have become standard treatment options for early-stage non-small cell lung cancer, significantly improving survival outcomes compared to conventional approaches. • Multiple clinical trials including CheckMate816, IMpower010, and KEYNOTE-671 demonstrate that patients with higher PD-L1 expression levels (≥50%) derive the greatest benefit from immunotherapy interventions, with some showing dramatic improvements in event-free survival. • Novel approaches targeting the adenosine pathway, such as the investigational A2a receptor antagonist JNJ-86974680, show promise in overcoming resistance to checkpoint inhibitors in advanced NSCLC patients who have progressed on prior immunotherapy.

DelveInsight Report: Over 50 Pipeline Drugs in Development for Urothelial Carcinoma Treatment

4 months ago

• DelveInsight's latest pipeline analysis reveals 40+ pharmaceutical companies actively developing 50+ therapeutic candidates for urothelial carcinoma treatment, indicating robust research activity in this space. • Major pharmaceutical companies including AstraZeneca, Seagen, and Janssen are advancing promising therapies, with notable candidates like disitamab vedotin and cetrelimab in late-stage development. • Recent clinical trials include Seagen's Phase 2 study of disitamab vedotin with pembrolizumab, and Roche's Phase 1b/II umbrella study investigating multiple combination therapies for advanced urothelial carcinoma.

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.

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.

RYBREVANT and LAZCLUZE Combination Shows Significant Survival Improvement in EGFR-Mutated NSCLC

5 months ago

• 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.

Disitamab Vedotin Plus Toripalimab Shows Promise in Muscle-Invasive Bladder Cancer

5 months ago

• Phase 2 trial RC48-C017 shows promising efficacy and acceptable safety of neoadjuvant disitamab vedotin plus perioperative toripalimab in HER2-expressing muscle-invasive bladder cancer (MIBC). • Pathological complete response (pCR) was observed in 63.6% of patients who underwent radical cystectomy, with a pathological response rate of 75.8%. • The 12-month event-free survival (EFS) rate was 90.5%, and the 12-month overall survival (OS) rate was 95.5% in the intent-to-treat (ITT) population. • Treatment-related adverse events were manageable, with no new safety signals identified, supporting the potential of this combination as a neoadjuvant treatment option.

TAR-200 Shows Promising Efficacy and Tolerability in BCG-Unresponsive NMIBC

5 months ago

• TAR-200, an intravesical gemcitabine-releasing system, demonstrates high complete response rates in patients with non-muscle-invasive bladder cancer (NMIBC) unresponsive to BCG therapy. • The SunRISe-1 trial highlights TAR-200's favorable safety profile, with most adverse events being low-grade and manageable with standard urological care. • Long-term data from SunRISe-1 indicates sustained efficacy, with complete response rates increasing over time, reaching up to 85% in some assessments. • Patients report psychological benefits from the continuous drug-releasing system, suggesting a positive impact on their perception of ongoing treatment.

Emerging Intravesical and Systemic Therapies Revolutionize Bladder Cancer Treatment

6 months ago

• Intravesical therapies like cretostimogene and TAR-200 show promising complete response rates in BCG-unresponsive NMIBC, but duration of response remains a key factor. • Perioperative systemic therapies, including neoadjuvant chemo-immunotherapy with durvalumab, aim to improve event-free and overall survival in muscle-invasive urothelial carcinoma. • Antibody-drug conjugates (ADCs) targeting Nectin-4 and HER2, such as enfortumab vedotin and disitamab vedotin, demonstrate significant potential in metastatic urothelial cancer. • Novel strategies, including dual-targeting antibodies and combinations of ADCs with immunotherapies, are being explored to further enhance treatment efficacy and overcome resistance.

XOMA Royalty Reports Q3 2024 Financial Results, Highlights Portfolio Expansion

6 months ago

• XOMA Royalty's portfolio expanded with FDA approval of Zevra's MIPLYFFA™ (arimoclomol) for Niemann-Pick disease Type C, marking its sixth commercial asset. • The company acquired a 50% economic interest in Twist Bioscience’s portfolio of over 60 licensed early-stage assets, diversifying its early-stage investments. • XOMA Royalty reported cash receipts of $9.9 million for Q3 2024 and $42.3 million for the first nine months, demonstrating strong financial performance. • Agenus Royalty Purchase Agreement led to a one-time, non-cash impairment charge of $14.0 million.

Keytruda Improves Survival in Head and Neck Cancer; Talzenna Prolongs Life in Prostate Cancer

7 months ago

• Merck's Keytruda, combined with adjuvant radiation therapy, significantly improved event-free survival in patients with resectable head and neck squamous cell cancer. • Pfizer's Talzenna, in combination with Xtandi, demonstrated improved overall survival in patients with metastatic castration-resistant prostate cancer compared to Xtandi alone. • A new FDA rule mandates healthcare providers to inform women about their breast density, impacting screening and risk assessment practices. • Research indicates that common breast cancer treatments may accelerate biological aging, highlighting the need for strategies to mitigate these long-term effects.

J&J Discontinues Phase III SunRISe-2 Trial of TAR-200/Cetrelimab in Muscle-Invasive Bladder Cancer

7 months ago

• Johnson & Johnson halted the Phase III SunRISe-2 trial of TAR-200 with cetrelimab for muscle-invasive bladder cancer (MIBC) after an interim analysis. • The independent data monitoring committee recommended discontinuation due to the combination not showing superiority over chemoradiation. • J&J remains confident in TAR-200's potential, particularly in bladder-sparing approaches, and plans to file for FDA approval of TAR-200 monotherapy in non-MIBC. • Ongoing SunRISe-3 and SunRISe-5 trials continue to evaluate TAR-200 in high-risk non-muscle invasive bladder cancer following Bacillus Calmette-Guérin (BCG) treatment.

TAR-200 Plus Cetrelimab Shows Promise in Muscle-Invasive Bladder Cancer

8 months ago

• Interim analysis of the SunRISe-4 study reveals that TAR-200 combined with cetrelimab demonstrates a 42% pathologic complete response rate in patients with muscle-invasive bladder cancer. • The combination therapy also achieved a 60% pathologic objective response rate, indicating a significant reduction in tumor size or elimination of the tumor. • Cetrelimab monotherapy showed a 23% pathologic complete response rate and a 36% pathologic objective response rate in the same patient population. • The TAR-200 and cetrelimab combination presented a manageable safety profile, suggesting it could be a viable neoadjuvant treatment option.

TAR-200 Shows High Complete Response Rate in BCG-Unresponsive NMIBC

8 months ago

• TAR-200 monotherapy demonstrated an 84% complete response rate in patients with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ. • The SunRISe-1 phase 2b study evaluated TAR-200 alone or with cetrelimab, showing durable responses without reinduction in the TAR-200 monotherapy arm. • TAR-200 was well-tolerated, with most adverse events being grade 1 or 2, supporting its prioritized development as a monotherapy for high-risk NMIBC. • These results offer a potential bladder-sparing alternative for patients who are ineligible or unwilling to undergo radical cystectomy, addressing a critical unmet need.

TAR-200 Demonstrates High Complete Response in BCG-Unresponsive Bladder Cancer

8 months ago

• TAR-200 monotherapy achieved an 83.5% complete response rate in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). • Durable complete responses were observed, with 82% of patients maintaining response after a median follow-up of 9 months, suggesting long-term efficacy. • The safety profile of TAR-200 was favorable, with low discontinuation rates due to treatment-related adverse events, supporting its potential as a monotherapy. • Cetrelimab monotherapy showed a 46.4% complete response rate, while the combination of TAR-200 and cetrelimab resulted in a 67.9% complete response rate.

Pfizer's Ponsegromab Shows Promise in Treating Cancer Cachexia in Phase 2 Trial

8 months ago

• Pfizer's ponsegromab met its primary endpoint in a Phase 2 trial, demonstrating a significant increase in body weight compared to placebo in cancer patients with cachexia. • The highest dose of ponsegromab resulted in a 5.61% mean increase in body weight after 12 weeks, along with improvements in appetite, physical activity, and muscle mass. • The investigational monoclonal antibody targets GDF-15, a key driver of cachexia, and was generally safe and well-tolerated across all dose levels. • Pfizer plans to initiate registration-enabling studies in 2025 based on these positive results, potentially offering a new treatment option for this debilitating condition.

Dexamethasone Significantly Reduces Infusion-Related Reactions with Amivantamab in EGFR-Mutated NSCLC

8 months ago

• A Phase 2 study showed that dexamethasone prophylaxis significantly reduced infusion-related reactions (IRRs) in patients with EGFR-mutated NSCLC treated with intravenous amivantamab. • The SKIPPirr study demonstrated a three-fold reduction in IRR incidence with dexamethasone pre-treatment compared to historical data using standard IRR management. • All infusion-related reactions observed in the study were Grade 1 or 2, with no hospitalizations or Grade 3 or higher events reported, indicating improved patient safety. • The safety profile of amivantamab and lazertinib with prophylactic dexamethasone was consistent with prior studies, suggesting the regimen is well-tolerated.

RYBREVANT Plus Chemotherapy Shows Positive Survival Trend in EGFR-Mutated Lung Cancer

8 months ago

• 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

9 months ago

• 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 Grants Breakthrough Therapy Designation to TAR-200 for BCG-Unresponsive NMIBC

a year ago

• The FDA granted Breakthrough Therapy Designation to TAR-200 for high-risk non-muscle-invasive bladder cancer (NMIBC) patients unresponsive to Bacillus Calmette-Guérin (BCG) who are ineligible for or decline radical cystectomy. • The designation is based on Phase 2b SunRISe-1 trial results, which showed a 76.7% complete response rate with TAR-200 monotherapy in BCG-unresponsive NMIBC patients. • TAR-200 is an investigational targeted releasing system that delivers gemcitabine into the bladder, providing sustained local drug exposure over several weeks. • Ongoing trials, including SunRISe-2, SunRISe-3, and SunRISe-4, are further evaluating TAR-200 in muscle-invasive and non-muscle-invasive bladder cancer settings.

Drug Development Updates