Cisplatin

Coherus and Junshi Biosciences Announce Publication of Positive Final Overall Survival Results of JUPITER-02, a Phase 3 Trial Evaluating LOQTORZI™ (toripalimab-tpzi) as Treatment for Nasopharyngeal Carcinoma, in the Journal of the American Medical Associa

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Dienstag, November 28, 2023
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REDWOOD CITY, Calif. And SHANGHAI, China, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180) announced today the publication of the final overall survival (OS) results from the pivotal JUPITER-02 study (NCT03581786), a randomized, double-blind, placebo-controlled, international, multi-center Phase 3 clinical trial evaluating the immune checkpoint inhibitor LOQTORZI™ (toripalimab-tpzi), in combination with the chemotherapy agents gemcitabine and cisplatin, as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) in the Journal of the American Medical Association (JAMA). As previously reported at the 2023 American Society of Clinical Oncologists (ASCO) Annual Meeting, the final analysis revealed a 37% reduction in the risk of death in NPC patients treated with toripalimab plus chemotherapy versus chemotherapy alone.

Key Points: 
  • Coherus plans to launch LOQTORZI in the United States in January 2024.
  • “There are limited options for patients living with this aggressive head and neck cancer.
  • The median OS was not reached in the LOQTORZI arm and was 33.7 months in the placebo arm.
  • The safety profile was consistent with that previously reported in other toripalimab clinical trials and consistent with the PD-1 inhibitor class.

Galera Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

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Dienstag, November 14, 2023
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MALVERN, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the third quarter ended September 30, 2023 and provided recent corporate updates.

Key Points: 
  • The Company is exploring potential strategic alternatives, as it is not feasible to conduct an additional trial with the Company’s current resources.
  • Research and development expenses were $6.1 million in the third quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $5.0 million in the third quarter of 2023, compared to $4.9 million for the same period in 2022.
  • As of September 30, 2023, Galera had cash, cash equivalents and short-term investments of $28.4 million.

Fennec Pharmaceuticals to Participate in Upcoming Investor Conferences

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Donnerstag, November 9, 2023
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RESEARCH TRIANGLE PARK, N.C., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Company will be participating in upcoming conferences.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Company will be participating in upcoming conferences.
  • The management team will also host one-on-one investor meetings at the conferences.
  • Event: Jefferies London Healthcare Conference in London, UK
    Time: Company Presentation at 5:00 a.m.
  • It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for New First-Line Indications in Advanced HER2-Negative Gastric or GEJ Adenocarcinoma in Tumors Expressing PD-L1 (CPS ≥1) and Advanced Biliary Tract Cancer

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Montag, Dezember 18, 2023
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In patients whose tumors expressed PD-L1 (CPS ≥1), KEYTRUDA plus chemotherapy reduced the risk of death by 26% (HR=0.74 [95% CI, 0.65-0.84]; p

Key Points: 
  • In patients whose tumors expressed PD-L1 (CPS ≥1), KEYTRUDA plus chemotherapy reduced the risk of death by 26% (HR=0.74 [95% CI, 0.65-0.84]; p
  • Median OS was 13.0 months (95% CI, 11.6-14.2) for patients treated with KEYTRUDA plus chemotherapy vs 11.4 months (95% CI, 10.5-12.0) for chemotherapy alone.
  • Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
  • In KEYNOTE-859, the incidence of Grade 3-5 adverse reactions in patients with gastric cancer was 75% for KEYTRUDA plus chemotherapy and 70% for chemotherapy.

Sensorion Provides an Update on NOTOXIS, its Proof of Concept Phase 2a Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity (CIO)

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Montag, Dezember 18, 2023
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The trial assesses several outcome measures, including the rate and severity of ototoxicity, the change from baseline in Pure Tone Audiometry (PTA) (dB) throughout the study and the tolerance.

Key Points: 
  • The trial assesses several outcome measures, including the rate and severity of ototoxicity, the change from baseline in Pure Tone Audiometry (PTA) (dB) throughout the study and the tolerance.
  • Géraldine Honnet, Chief Medical Officer of Sensorion, said: “I’m pleased with the progress in Sensorion’s POC Phase 2a clinical study of SENS-401 in the prevention of Cisplatin-Induced Ototoxicity.
  • SENS-401 is also progressing in a second ongoing Phase 2a clinical study in the prevention of residual hearing loss following cochlear implantation.
  • Sensorion is anticipating the end of patient recruitment early 2024 and the publication of POC Phase 2a clinical primary endpoint readout in H1 2024.

PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

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Freitag, Dezember 15, 2023
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This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

Key Points: 
  • This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.
  • Findings from EV-302 were presented at the European Society for Medical Oncology (ESMO) Congress 2023 .
  • “In the Phase 3 EV-302 study, the combination of PADCEV and pembrolizumab demonstrated survival benefit for patients with advanced bladder cancer, nearly doubling median OS and median PFS compared with chemotherapy.
  • Our network is thrilled that the FDA has approved a new treatment option, and we are excited about the hope it will provide to members of the bladder cancer patient community.”

FDA Approves Expanded Indication for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Cancer

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Freitag, Dezember 15, 2023
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KEYTRUDA plus enfortumab vedotin reduced the risk of death by 53% (HR=0.47 [95% CI, 0.38-0.58]; p

Key Points: 
  • KEYTRUDA plus enfortumab vedotin reduced the risk of death by 53% (HR=0.47 [95% CI, 0.38-0.58]; p
  • Median OS was 31.5 months (95% CI, 25.4-not reached) for KEYTRUDA plus enfortumab vedotin versus 16.1 months (95% CI, 13.9-18.3) for platinum-based chemotherapy.
  • KEYTRUDA plus enfortumab vedotin reduced the risk of disease progression or death by 55% (HR=0.45 [95% CI, 0.38-0.54]; p
  • Median PFS was 12.5 months (95% CI, 10.4-16.6) for KEYTRUDA plus enfortumab vedotin versus 6.3 months (95% CI, 6.2-6.5) for platinum-based chemotherapy.

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic...

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Dienstag, Dezember 5, 2023
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The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.

Key Points: 
  • The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.
  • “The FDA’s acceptance of our application for Opdivo in combination with cisplatin-based chemotherapy represents important progress toward addressing the unmet need for options that may offer durable responses and improved survival for patients with metastatic urothelial carcinoma.
  • The OS and PFS data from CheckMate -901 were presented at the European Society of Medical Oncology (ESMO) Congress 2023 .
  • The safety profile was tolerable and consistent with the known safety profiles of the individual components of the regimen.

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

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Donnerstag, November 30, 2023
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Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.
  • The FDA is reviewing the application under its Real-Time Oncology Review (RTOR) program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
  • If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients.
  • In February 2020, PADCEV in combination with KEYTRUDA was granted Breakthrough Therapy designation by the FDA and the EV-103 sBLA received Priority Review designation in December 2022.

FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Donnerstag, November 30, 2023
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This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible.

Key Points: 
  • This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 9, 2024.
  • KEYTRUDA plus enfortumab vedotin also achieved a significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 55% (median PFS, 12.5 months vs. 6.3 months, respectively); (HR=0.45 [95% CI, 0.38-0.54]; p
  • Results were consistent across all pre-defined subgroups, including patients who may or may not be eligible for treatment with cisplatin-based chemotherapy as well as patients whose tumors expressed both high (Combined Positive Score [CPS] ≥10) or low (CPS