A new European approval for Bristol-Myers’ immunotherapy opdivo. The future is starting now

The Future is Starting Now

Recognizing that the future has already started now is important as it makes analysts use different criteria for the fair evaluation of the future growth of biotechnology startups and revenue-generating companies. This is our main topic the Prohost Letter that we are working diligently working on posting at any time now. This is extremely important to know before the hype and the fabrications distort the reality of what’s going on in the mind of investors in the drug developing world.

In the NEWS

Bristol-Myers and Immunotherapy. Europe Grants New Approvals of Opdivo for Melanoma

Today’s news from Bristo-Myers (BMY) reveals that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma that involved lymph nodes or metastatic disease patients who have undergone complete resection. Th new indication is for both BRAF mutant and wild-type melanoma patients.

Following the new approval, Opdivo becomes the first and only PD-1 therapy to be granted an EC approval in the adjuvant setting. This is  Opdivo’s eighth indication granted across six distinct tumor types in the European Union (EU).

James Larkin, M.D., Ph.D., Consultant Medical Oncologist, The Royal Marsden said, “Stage III and stage IV melanoma patients are at high risk for disease recurrence after surgical removal and, therefore, in need of effective interventions to prevent recurrence. This is an important new treatment option, as the data support the benefit of nivolumab across a broad range of patients to address concerns around recurrence post-surgery.”

The EU approval is based on results from the CheckMate -238 trial that studied Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma.

The 18-month recurrence-free survival (RFS) was 66.4% for Opdivo (95% CI: 61.8 to 70.6) versus 52.7% for Yervoy.

– Opdivo reduced the risk of disease recurrence by 35% versus Yervoy.

Opdivo was well tolerated, with 14.4% of patients experiencing treatment-related grade 3/4 adverse events and 9.7% discontinuing due to toxicity.

CheckMate-238 is an ongoing Phase 3, randomized double-blind study of Opdivo versus Yervoy in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma. The trial randomized 906 patients 1:1 to receive either Opdivo 3 mg/kg every two weeks (n=453) or Yervoy 10 mg/kg (n=453) every three weeks for four doses and then every 12 weeks starting at week 24. Patients were treated until disease recurrence, unacceptable toxicity or withdrawal of consent for up to one year. The primary endpoint is recurrence-free survival (RFS), defined as the time between randomization and the date of first recurrence, new primary melanoma or death. After meeting the primary endpoint, the trial will continue to evaluate for overall survival, a secondary endpoint.

Adjuvant Therapy in Melanoma Melanoma is separated into five staging categories (stages 0 to IV) based on the size or thickness of the tumor, whether or not it has spread to the lymph nodes or other organs, and certain other characteristics, such as growth rate.

Stage III melanoma has reached the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized), and requires surgical resection of the primary tumor as well as the involved lymph nodes. Some patients may also be treated with adjuvant therapy. Despite surgical intervention and possible adjuvant treatment, most patients experience disease recurrence and progress to metastatic disease. By five years, the majority of stage IIIB and IIIC patients (68% and 89%, respectively) experience disease recurrence

Prohost Observations

In addition to gene therapy and other novel treatments, we consider immuno-oncology as the future being practiced today and people should be aware of these breakthrough treatments’ importance and values.  Precisely stated, Investors must not be misled by erroneous interpretations to researchers’ finding to abandon firms that are bringing the future into today as we are witnessing happen following each study researchers publish in good faith for the sake of advancing and improving on what is obviously becoming true facts.

Bristol-Myers Squibb is, indeed, a company with vision on the future of cancer care through its  efforts spent on developing transformational medicines, Immuno-Oncology (I-O) therapeutic approaches are a major part of these unparalleled efforts.

Immunotherapy has already changed patients’ lives thanks to BMY, Merck, Roche and other firms that are discovering more immune checkpoints and developing monoclonal antibodies to inhibit them, hence relieving the pressure made by these checkpoints on the immune system, preventing it from fighting malignancies.

Do Not miss the upcoming Prohost Letter #423.

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