Melanoma

Replimune Provides RP1 Data Update from its Phase 2 Cohorts in Melanoma and Non-Melanoma Skin Cancer that Strongly Support Replimune’s Ongoing Registration-Directed Clinical Trials with RP1

Wednesday, June 3, 2020 - 12:00pm

The Companys registration-directed Phase 2 clinical trial (CERPASS) in CSCC is a multi-center, randomized, controlled clinical trial intended to enroll approximately 240 patients.

Key Points: 
  • The Companys registration-directed Phase 2 clinical trial (CERPASS) in CSCC is a multi-center, randomized, controlled clinical trial intended to enroll approximately 240 patients.
  • The primary objective is to compare the response rate following treatment with RP1 in combination with Libtayo versus Libtayo alone.
  • This includes eight patients with anti-PD-1 nave cutaneous melanoma, six patients with mucosal melanoma and six patients with uveal melanoma.
  • Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin.

Provectus Announces Presentation of Updated Data from Metastatic Uveal Melanoma Cohort of Phase 1 PV-10® Study at American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program

Monday, June 1, 2020 - 2:00pm

Response assessments using European Association of the Study of the Liver (2D-EASL) criteria are performed at Day 28, and then every three months.

Key Points: 
  • Response assessments using European Association of the Study of the Liver (2D-EASL) criteria are performed at Day 28, and then every three months.
  • Patients with additional injectable tumors and/or unresponsive injected tumors may receive additional PV-10 after Day 28.
  • This study is now enrolling patients into a single-center cohort at MDACC of up to 25 uveal melanoma patients with hepatic metastases.
  • Eligible patients may also receive standard of care CB during and after treatment with PV-10.

Iovance Presents Updated Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel in Advanced Melanoma at ASCO Scientific Program

Friday, May 29, 2020 - 1:01pm

We are very pleased to present the long term follow up data for lifileucel in melanoma at the ASCO Scientific Program, said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics.

Key Points: 
  • We are very pleased to present the long term follow up data for lifileucel in melanoma at the ASCO Scientific Program, said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics.
  • The median duration of response has not been reached at 18.7 months of study follow up supporting potential benefit of the one-time treatment of lifileucel TIL therapy in advanced melanoma patients.
  • Updated interim results from Cohort 2 are now available from an oral abstract session titled, Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies.
  • A clinical study to investigate Iovance T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is open to enrollment.

Achilles Therapeutics doses first patient in Phase I/II Study in recurrent or metastatic malignant melanoma

Friday, May 29, 2020 - 12:00pm

Stevenage, UK 29 May 2020 Achilles Therapeutics (Achilles), a clinical stage biopharmaceutical company developing personalised cancer immunotherapies, today announced that it has dosed the first patient in a Phase I/II study of a clonal neoantigen T cell (cNeT) therapy in patients with recurrent or metastatic malignant melanoma.

Key Points: 
  • Stevenage, UK 29 May 2020 Achilles Therapeutics (Achilles), a clinical stage biopharmaceutical company developing personalised cancer immunotherapies, today announced that it has dosed the first patient in a Phase I/II study of a clonal neoantigen T cell (cNeT) therapy in patients with recurrent or metastatic malignant melanoma.
  • The THETIS study is an open-label, multi-centre Phase I/II trial evaluating the safety, tolerability and clinical efficacy of cNeT therapy as a single dose in patients with recurrent or metastatic malignant melanoma.
  • The dosing of our first melanoma patient with a cell therapy to specifically target all cancer cells, marks a significant milestone in delivering the first precision TIL therapy.
  • Achilles uses its proprietary process to manufacture T cells (cNeT) which exquisitely target a specific set of clonal neoantigens in each patient.

Achilles Therapeutics doses first patient in Phase I/II Study in recurrent or metastatic malignant melanoma

Friday, May 29, 2020 - 7:00am

Stevenage, UK 29 May 2020 Achilles Therapeutics (Achilles), a clinical stage biopharmaceutical company developing personalised cancer immunotherapies, today announced that it has dosed the first patient in a Phase I/II study of a clonal neoantigen T cell (cNeT) therapy in patients with recurrent or metastatic malignant melanoma.

Key Points: 
  • Stevenage, UK 29 May 2020 Achilles Therapeutics (Achilles), a clinical stage biopharmaceutical company developing personalised cancer immunotherapies, today announced that it has dosed the first patient in a Phase I/II study of a clonal neoantigen T cell (cNeT) therapy in patients with recurrent or metastatic malignant melanoma.
  • The THETIS study is an open-label, multi-centre Phase I/II trial evaluating the safety, tolerability and clinical efficacy of cNeT therapy as a single dose in patients with recurrent or metastatic malignant melanoma.
  • The dosing of our first melanoma patient with a cell therapy to specifically target all cancer cells, marks a significant milestone in delivering the first precision TIL therapy.
  • Achilles uses its proprietary process to manufacture T cells (cNeT) which exquisitely target a specific set of clonal neoantigens in each patient.

Iovance Reports Pivotal Cohort 4 Data for Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel from C-144-01 Clinical Study in Advanced Melanoma

Wednesday, May 27, 2020 - 9:01pm

We are very pleased to announce our pivotal Cohort 4 early data from the C-144-01 clinical study in advanced melanoma today, said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics.

Key Points: 
  • We are very pleased to announce our pivotal Cohort 4 early data from the C-144-01 clinical study in advanced melanoma today, said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics.
  • Together, these early data continue to support the potential benefit of the one-time administration of lifileucel TIL therapy in advanced melanoma patients.
  • Initial results from the pivotal Cohort 4 in the C-144-01 clinical study is available for 68 patients with two radiological assessments, as determined by investigator.
  • A clinical study to investigate Iovance T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is open to enrollment.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer

Tuesday, May 26, 2020 - 10:48pm

In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients.

Key Points: 
  • In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients.
  • In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients.
  • When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis.
  • In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

Immunocore announces dosing of first patient with fourth ImmTAC®

Tuesday, May 26, 2020 - 12:00pm

Wholly owned IMC-F106C is focused on targeting tumours that express PRAME, a cancer-testis antigen (CTA) that is highly expressed in a broad range of solid and hematologic malignancies, and is being developed by Immunocore.

Key Points: 
  • Wholly owned IMC-F106C is focused on targeting tumours that express PRAME, a cancer-testis antigen (CTA) that is highly expressed in a broad range of solid and hematologic malignancies, and is being developed by Immunocore.
  • The Companys most advanced programmes are in oncology and it has a rich pipeline of programmes in infectious and autoimmune diseases.
  • Immunocores lead programme, tebentafusp (IMCgp100), has entered pivotal clinical studies as a treatment for patients with metastatic uveal melanoma.
  • Immunocore is headquartered at Milton Park, Oxfordshire, UK, with offices in Conshohocken, Pennsylvania and Rockville, Maryland in the US.

DermTech PLA Included in Peer Review Article of Novel Molecular Technologies for Melanoma Management with Potential to Address Current Gaps in Diagnostic Accuracy and Prognostication

Wednesday, May 20, 2020 - 9:30pm

The review examined the fundamental principles behind each test, peer-reviewed literature assessing tool performance, and the utility and limitations of each assay.

Key Points: 
  • The review examined the fundamental principles behind each test, peer-reviewed literature assessing tool performance, and the utility and limitations of each assay.
  • The published summary cites six peer-reviewed studies of the DermTech PLA.
  • Early melanoma detection is very challenging, and the DermTech PLA can reduce unnecessary pain and scarring from surgical biopsies, while improving the overall accuracy of diagnosis.
  • As the authors note, the DermTech PLA is validated with proven clinical utility and a high sensitivity and low probability of missing melanoma.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%

Friday, May 15, 2020 - 8:56pm

In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients.

Key Points: 
  • In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients.
  • In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients.
  • In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients.
  • In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.