Melanoma

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Retrieved on: 
Friday, February 16, 2024

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Key Points: 
  • This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response.
  • AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer.
  • “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.
  • Iovance will host a conference call and live audio webcast today to discuss the FDA approval of AMTAGVI.

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Retrieved on: 
Friday, February 16, 2024

"Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).

Key Points: 
  • "Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).
  • Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.
  • Treatment for unresectable or metastatic melanoma may include immunotherapy using PD-1 inhibitors, which are antibodies targeting certain proteins in the body to help the immune system fight off cancer cells.
  • Those patients whose melanoma has progressed with these therapies have a high unmet medical need.

New Guidance Published in The Lancet Recommends Early Intervention and Use of BIS to Reduce Impact of Arm Lymphedema on Breast Cancer Patients

Retrieved on: 
Thursday, February 15, 2024

CARLSBAD, Calif., Feb. 15, 2024 /PRNewswire/ -- ImpediMed, a pioneer in the field of medical technology, announced a significant advancement in the fight against breast cancer-related lymphedema, a common but often overlooked condition affecting breast cancer survivors. Leading medical journal eClinicalMedicine, part of The Lancet Discovery Science, recently published new clinical guidance advocating for early detection and prevention strategies, underscoring the validity and efficacy of ImpediMed's innovative approach.

Key Points: 
  • Leading medical journal eClinicalMedicine, part of The Lancet Discovery Science, recently published new clinical guidance advocating for early detection and prevention strategies, underscoring the validity and efficacy of ImpediMed's innovative approach.
  • At the center of these recommendations is bioimpedance spectroscopy (BIS), a cutting-edge technology pioneered by ImpediMed, designed to help detect lymphedema in its early stages before it becomes a significant problem.
  • According to the American Cancer Society 58% of cancer patients diagnosed with breast cancer, melanoma, or pelvic area cancers are at risk for developing limb lymphedema, and over 80% of breast cancer patients are at risk.
  • The Company's SOZO® Digital Health Platform is broadly accepted and recognized for effective and accurate screening of lymphedema.

What are ‘collarium’ sunbeds? Here’s why you should stay away

Retrieved on: 
Wednesday, February 14, 2024

A collarium sunbed emits both UV radiation and a mix of visible wavelength colours to produce a pink or red light.

Key Points: 
  • A collarium sunbed emits both UV radiation and a mix of visible wavelength colours to produce a pink or red light.
  • Like an old-school sunbed, the user lies in it for ten to 20 minute sessions to quickly develop a tan.

Why were sunbeds banned?

  • Commercial sunbeds have been illegal across Australia since 2016 (except for in the Northern Territory) under state-based radiation safety laws.
  • Their dangers were highlighted by young Australians including Clare Oliver who developed melanoma after using sunbeds.
  • Research shows people who have used sunbeds at least once have a 41% increased risk of developing melanoma, while ten or more sunbed sessions led to a 100% increased risk.

How are collarium sunbeds supposed to be different?

  • Australian sellers of collarium sunbeds imply they are safe, but their machine descriptions note the use of UV radiation, particularly UVA.
  • UVA is one part of the spectrum of UV radiation.
  • Evidence shows all types of sunbeds increase the risk of melanoma, including those that use only UVA.

Collagen claims

  • One particularly odd claim about collarium sunbeds is that they stimulate collagen.
  • Collagen is the main supportive tissue in our skin.
  • The reactive oxygen species generated by UVA light damage existing collagen structures and kick off a molecular chain of events that downgrades collagen-producing enzymes and increases collagen-destroying enzymes.
  • Over time, a build-up of degraded collagen fragments in the skin promotes even more destruction.

What about phototherapy?

  • The anti-collagen effects of UVA can also be used to treat thickened scars and keloids.
  • Side-effects of UV phototherapy include tanning, itchiness, dryness, cold sore virus reactivation and, notably, premature skin ageing.

So what happens now?

  • It looks like many collariums are just sunbeds rebranded with red light.
  • Queensland Health is currently investigating whether these salons are breaching the state’s Radiation Safety Act, and operators could face large fines.


Katie Lee receives funding from the National Health and Medical Research Council. Anne Cust receives funding from the National Health and Medical Research Council and Medical Research Future Fund.

Medicenna Therapeutics Reports Third Quarter Fiscal 2024 Financial Results and Corporate Update

Retrieved on: 
Wednesday, February 14, 2024

Today, the Company reports promising clinical data from the on-going monotherapy escalation and expansion arms of the ABILITY-1 study.

Key Points: 
  • Today, the Company reports promising clinical data from the on-going monotherapy escalation and expansion arms of the ABILITY-1 study.
  • Clinical update from the combination arm of the ABILITY-1 study evaluating MDNA11 in with KEYTRUDA® expected in H1 and H2 of 2024.
  • Research and development expenses of $3.0 million were incurred during the quarter ended December 31, 2023, compared with $2.9 million incurred in the quarter ended December 31, 2022.
  • General and administrative expenses of $1.8 million were incurred during the quarter ended December 31, 2023, compared with $2.0 million during the quarter ended December 31, 2022.

Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials

Retrieved on: 
Wednesday, February 14, 2024

SAN DIEGO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced two clinical trial collaboration and supply agreements (CTCSAs) with Novartis (NYSE: NVS) for the MEK inhibitor trametinib (MEKINIST®).

Key Points: 
  • Erasca is sponsoring the trials, and Novartis is supplying trametinib at no cost.
  • “Both trials are supported by compelling anti-tumor activity with a tolerable and manageable adverse event profile demonstrated in clinical data generated by Novartis.
  • Both RAS Q61X solid tumors and NRASm melanoma represent high unmet needs with no approved targeted therapies for these respective mutation types.
  • Erasca is exploring whether naporafenib in combination with trametinib can improve outcomes and help provide meaningful therapeutic benefit for these advanced solid tumor indications.

Quest Diagnostics Debuts MelaNodal Predict™ Test, Personalizing Melanoma Risk Prediction to Help Patients Forgo Invasive Surgery

Retrieved on: 
Tuesday, February 13, 2024

SECAUCUS, N.J., and SAN DIEGO, Feb. 13, 2024 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the nation's leading provider of diagnostic information services, today announced the launch of MelaNodal Predict™, a highly advanced predictive gene expression test to help personalize treatment decisions for patients with melanoma, the deadliest form of skin cancer and one of the most common cancers in the United States.1 Dermatologists and other providers nationwide may begin ordering the test today from Quest Diagnostics, as well as through Dermpath Diagnostics, Quest's subspecialty pathology business.

Key Points: 
  • MelaNodal Predict is a lab-developed test validated by Quest Diagnostics and based on technology developed by SkylineDx, an oncology biotechnology company, alongside Mayo Clinic.
  • MelaNodal Predict examines a patient's original diagnostic tumor biopsy and applies an algorithm to help providers identify patients with a low or high risk of nodal metastasis (melanoma that has spread to the lymph nodes).
  • This insight may help providers identify patients that could, with less risk, avoid a potentially unnecessary, expensive and invasive surgery called a sentinel lymph node biopsy (SLNB).
  • The MelaNodal Predict test's results will help physicians identify their patient's risk of metastasis to assist in individualizing surgical decisions and patient management plans."

Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 8, 2024

WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.

Key Points: 
  • WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.
  • We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024.
  • Selling, general and administrative expenses included $4.5 million in stock-based compensation expenses for the third quarter ended December 31, 2023.
  • Net Loss: Net loss was $51.1 million for the third quarter ended December 31, 2023, as compared to a net loss of $39.7 million for the third quarter ended December 31, 2022.

Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, February 7, 2024

Bristol Myers Squibb (NYSE: BMY) today announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).
  • "Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence.
  • The study also showed benefits in key secondary endpoints including pathologic complete response (pCR) and major pathologic response (MPR).
  • Opdivo and Opdivo-based combinations have shown efficacy benefits in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

AMERICAN ACADEMY OF DERMATOLOGY SURVEY SHOWS SUN PROTECTION LACKING IN WINTER

Retrieved on: 
Tuesday, February 6, 2024

ROSEMONT, Ill., Feb. 6, 2024 /PRNewswire/ -- A recent American Academy of Dermatology survey1 revealed that nearly one in five adults are not aware that you can get sunburned during the winter, and even fewer protect themselves from the sun before common outdoor activities in cold weather.

Key Points: 
  • According to the survey, one in seven Americans are unaware that the sun's UV rays are reflected by snow, water, and sand.
  • "Many people don't realize that you need to use sun protection in the winter," said Dawn Davis, MD, FAAD, a board-certified dermatologist and professor of dermatology at Mayo Clinic Rochester.
  • Only 13% of Americans plan to use sun protection when going for walks or hikes in cold weather.
  • "Sun protection is vitally important because ultraviolet (UV) rays are always present, regardless of the season or time of day," said Dr. Davis.