Positive Results from First Randomized Study Assessing T-VEC/Ipilimumab Combo in Advanced Melanoma

Excerpt:

“The addition of T-VEC (T-VEC; Imlygic), a herpes simplex virus 1-based oncolytic virus, to CTLA-4 inhibitor ipilimumab (Yervoy) improves the objective response rate (ORR) in patients with unresected stage IIIb to IV melanoma, according to findings presented at the 7th European Post-Chicago Melanoma/Skin Cancer Meeting.

“T-VEC was the first approved oncolytic virus therapy in Europe, the United States, and Australia, and its efficacy was previously demonstrated in a phase III trial comprising patients with advanced unresectable melanoma.”

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Study Moves T-VEC Into Neoadjuvant Melanoma Setting

Excerpt:

“Talimogene laherparepvec (T-VEC; Imlygic), an oncolytic viral immunotherapy approved for patients with melanoma, is being evaluated in a presurgical setting in a phase II clinical trial that may help set the stage for expanding the toolkit of neoadjuvant options for patients with the malignancy.

“Although new targeted and immunotherapy agents for patients with melanoma have been introduced in recent years in advanced and metastatic settings, there is a need for approaches that attack the disease earlier and prevent recurrence, said Robert H.I. Andtbacka, MD, the principal investigator for the T-VEC study. ‘I think it’s the next logical step for us to take in melanoma—to try to find better ways to activate the patient’s own immune system where the tumor is still in situ,’ Andtbacka said in an interview with OncLive. ‘Many of our colleagues in other tumor sites such as breast cancer and colon cancer have done this for many, many years, so we’ve been lagging a little bit behind in melanoma. But now I think we have good, effective therapies that we can start to ask these neoadjuvant questions.’ ”

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Talimogene Laherparepvec, Pembrolizumab Combination Safely Treats Advanced Melanoma

Excerpt:

“Patients with advanced unresectable melanoma can safely receive combination therapy with full doses of talimogene laherparepvec and pembrolizumab, according to study results presented at HemOnc TodayMelanoma and Cutaneous Malignancies.

“In previous studies, talimogene laherparepvec (Imlygic, Amgen) — a herpes simplex virus-1-based oncolytic immunotherapy — significantly improved durable response rate in patients with advanced melanoma. Also, pembrolizumab (Keytruda, Merck) — an anti–PD-1 antibody — showed superiority over ipilimumab (Yervoy, Bristol Meyers Squibb) in patients with stage III or IV melanoma.

“Both drugs appeared tolerable and demonstrated nonoverlapping adverse event profiles…”

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OPTiM Follow-up Shows Improved CR Rate With T-VEC in Melanoma

“A retrospective analysis of the phase III OPTiM study found that treatment with talimogene laherparepvec (T-VEC; Imlygic) resulted in complete responses (CR) in 17% of patients seen in all stages of melanoma. Median time to achieve a CR was 8.6 (6.0–13.6) months. A high proportion of response occurred in patients with early-stage disease and lower tumor burden, according to study authors.

“In OPTiM, a phase III trial in 436 patients with unresected stage IIIB to IV melanoma, T-VEC improved durable response rates from 2.1% to 16.3% versus subcutaneous GM-CSF. Overall response rates (ORR) for T-VEC and GM-CSF were 26.4% and 5.7%, respectively. Median overall survival (OS) was 23.3 months with T-VEC and 18.9 months with GM-CSF (HR, 0.79; 95% CI, 0.62–1.00; P = .051).”


The Growing Arsenal of Immunotherapy Drugs for Melanoma


Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago. Continue reading…


Amgen Receives CHMP Positive Opinion For IMLYGIC™ (Talimogene Laherparepvec)

“Amgen AMGN, +1.94% today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. If approved by the European Commission, IMLYGIC would be the first in a class of novel agents known as oncolytic immunotherapies.

“IMLYGIC, administered via intralesional injection, is designed to cause the death of tumor cells and to initiate an anti-tumor immune response.”