Antineoplastic drugs

Istari Oncology Announces FDA Granted Fast Track Designation to PVSRIPO for the Treatment of Advanced Melanoma

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Monday, June 14, 2021

In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.

Key Points:

In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.
Treatment-resistant, advanced melanoma patients have very poor survival rates, with less than 30% of metastatic melanoma patients surviving 5 years1.
Fast Track is an FDA program designed to facilitate the expedited development of drugs to treat serious conditions and address an unmet medical need.
We are thrilled with FDAs decision to grant both Fast Track and Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma, said Matt Stober, President and Chief Executive Officer at Istari Oncology.

Infinity to Present at The Keystone Symposia Precision Oncology Meeting

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Monday, June 14, 2021

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Drugs, Health sciences, Clinical medicine, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Immune system, Cancer immunotherapy, Programmed cell death protein 1, Nivolumab, Eganelisib, Clinical trial

Infinity Pharmaceuticals, Inc. (Infinity or the Company), is a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies.

Key Points:

Infinity Pharmaceuticals, Inc. (Infinity or the Company), is a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies.
MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.
With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-nave, and front-line settings.
For more information on Infinity, please refer to Infinity's website at www.infi.com .

DESTINY-Breast09 Head-to-Head First-Line Phase 3 Trial of ENHERTU® Initiated in Patients with HER2 Positive Metastatic Breast Cancer

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Monday, June 14, 2021

This is the first trial to evaluate ENHERTU in the first-line metastatic setting in patients with HER2 positive breast cancer.

Key Points:

This is the first trial to evaluate ENHERTU in the first-line metastatic setting in patients with HER2 positive breast cancer.
In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients.
In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4mg/kg, a decrease in neutrophil count was reported in 62% of patients.
In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported.

Exelixis Announces Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Evaluate XL092 in Combination with Immuno-oncology Therapies in Advanced Solid Tumors

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Monday, June 14, 2021

Exelixis, Inc. (Nasdaq: EXEL) today announced a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.

Key Points:

Exelixis, Inc. (Nasdaq: EXEL) today announced a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.
Exelixis is sponsoring STELLAR-002 and Bristol Myers Squibb will provide nivolumab, ipilimumab and bempegaldesleukin for use in the trial.
STELLAR-002 will begin with a dose-escalation phase to determine the recommend dose for each of the XL092 combination therapies: XL092 in combination with nivolumab, XL092 in combination with nivolumab and ipilimumab and XL092 in combination with nivolumab and bempegaldesleukin.
XL092 is the first internally discovered Exelixis compound to enter the clinic following the companys reinitiation of drug discovery activities.

ALX Oncology Announces Update on ASPEN-03 and ASPEN-04, the ALX148 Phase 2 Head and Neck Cancer Studies

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Monday, June 14, 2021

Cancer treatments, Clinical medicine, Medicine, Cancer immunotherapy, Immune system, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Pembrolizumab, Checkpoint inhibitor, Myelodysplastic syndrome, Oncology

The two randomized Phase 2 studies, ASPEN-03 and ASPEN-04, are potentially registrational with patient enrollment unimpacted in either study.

Key Points:

The two randomized Phase 2 studies, ASPEN-03 and ASPEN-04, are potentially registrational with patient enrollment unimpacted in either study.
ALX Oncology is advancing ALX148 into two randomized Phase 2 studies in subjects with HNSCC in combination with pembrolizumab, marketed as KEYTRUDA, the market leading anti-programmed cell death protein-1, or PD-1, checkpoint inhibitor, with or without chemotherapy.
ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndromes (MDS).
Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia

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Saturday, June 12, 2021

Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Drugs, Orphan drugs, Breakthrough therapy, Tyrosine kinase inhibitors, Antineoplastic drugs, Ibrutinib, Pyrazolopyrimidines, Chronic lymphocytic leukemia, Venetoclax, Obinutuzumab

Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.

Key Points:

Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.
Waldenstrms macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients.
Fixed-Duration Ibrutinib Plus Venetoclax (I+V) Versus Chlorambucil Plus Obinutuzumab (Clb+O) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL): Primary Analysis of the Phase 3 GLOW Study.
Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study Leukemia.

Sorrento Announces Clinical Research Agreement With Mayo Clinic and FDA Clearance for the First Phase 1b Pilot Study Using Sofusa Lymphatic Drug Delivery Technology to Deliver Ipilimumab in Patients With Melanoma

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Friday, June 11, 2021

Bristol-Myers Squibb, Drugs, Clinical medicine, Cancer, Medicine, Ipilimumab, Melanoma, Breakthrough therapy, Orphan drugs, Antineoplastic drugs

The first study resulting in this agreement is MC20711, a Phase 1b study of the administration of Ipilimumab Intra-Lymphatically using the Sofusa DoseConnect in Patients with Metastatic Melanoma.

Key Points:

The first study resulting in this agreement is MC20711, a Phase 1b study of the administration of Ipilimumab Intra-Lymphatically using the Sofusa DoseConnect in Patients with Metastatic Melanoma.
This agreement builds upon the previously announced exclusive licensing agreement where Sorrento licensed Mayo Clinics proprietary Antibody-Drug-Nanoparticle albumin-bound Immune Complex platform technology.
Mayo Clinic, Dr. Svetomir Markovic and Dr. James Jakub have financial interests in the technology referenced in this release.
RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients.

Genentech Announces Data at EHA2021 Reinforcing Efficacy of Venclexta Combinations in Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia

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Friday, June 11, 2021

The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, M.D., University of Cologne.

Key Points:

The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, M.D., University of Cologne.
Following a five-week dose ramp-up schedule for Venclexta patients on the Venclexta plus Rituxan arm received six cycles of Venclexta plus Rituxan followed by Venclexta monotherapy for up to two years total.
The study included 389 patients with chronic lymphocytic leukemia (CLL), with or without 17p deletion, who had been previously treated with at least one line of therapy.
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology.

CBMG Holdings' Novel CD19/CD20 Bi-specific CAR-T Cell Product Shows Early Promising Clinical Efficacy and Favorable Safety Profile in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

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Thursday, June 10, 2021

Medical specialties, Anatomical pathology, Hematology, Lymphoma, Clinical medicine, Medicine, Orphan drugs, Antineoplastic drugs, Copanlisib

"C-CAR039 preliminary data has demonstrated an early favorable safety profile and encouraging efficacy in clinical trial in patients with r/r B-NHL," commented Tony (Bizuo) Liu, Chairman and CEO of CBMG Holdings.

Key Points:

"C-CAR039 preliminary data has demonstrated an early favorable safety profile and encouraging efficacy in clinical trial in patients with r/r B-NHL," commented Tony (Bizuo) Liu, Chairman and CEO of CBMG Holdings.
We are also pleased that the FDA has recognized C-CAR039's potential as a treatment option for follicular lymphoma in granting it ODD.
This designation speaks to our therapy already showing promise in treating such serious illness and marks another significant regulatory milestone for our C-CAR039 product.
Dose escalation and expansion studies were conducted to evaluate the safety and efficacy of C-CAR039 in r/r B-NHL patients.

Cue Biopharma Announces First Patient Dosed in Part B Patient Expansion of CUE-101 Phase 1 Monotherapy Trial in HPV+ Second Line and Beyond HNSCC

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Thursday, June 10, 2021

Cancer, Clinical medicine, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Cancer immunotherapy, Otorhinolaryngology, Pembrolizumab, Head and neck cancer, Human papillomavirus infection

The Phase 1b portion of the CUE-101 monotherapy clinical trial in patients with HPV+ second line and beyond (2L+) head and neck squamous cell carcinoma (HNSCC) is expected to enroll up to 20 patients.

Key Points:

The Phase 1b portion of the CUE-101 monotherapy clinical trial in patients with HPV+ second line and beyond (2L+) head and neck squamous cell carcinoma (HNSCC) is expected to enroll up to 20 patients.
We are very pleased to have initiated the Part B patient expansion of the CUE-101 monotherapy trial, stated Ken Pienta, M.D., acting chief medical officer of Cue Biopharma.
Based on translational data from the Phase 1a portion of the trial, a recommended Phase 2 dose has been determined.
The company has expanded the study to evaluate CUE-101 in combination with KEYTRUDA (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC.