T-VEC, Ipilimumab Regimen Improves Survival in Advanced Melanoma

Excerpt:

“The combination of an oncolytic virus plus a checkpoint inhibitor improved survival among patients with advanced melanoma compared with monotherapy, according to data from a phase 2 study published in Journal of Clinical Oncology.

“Novel monotherapies, such as ipilimumab (Yervoy, Bristol-Myers Squibb) — a CTLA-4 antibody — have ‘transformed patient care in advanced melanoma,’ the researchers wrote.”

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New Trends in Pre-Surgery Treatments for Breast Cancer


Non-metastatic breast cancers are most often treated with surgery, but if the tumors are fairly large, or involve nearby lymph nodes, neoadjuvant (pre-operative) treatments with chemotherapy (NAC) are done first. NAC often reduces the tumor size and kills cancer cells in lymph nodes, if present, prior to surgery, improving the outcome. The best possible result of neoadjuvant treatment is pCR (pathologic compete response), when the tumor is no longer visible in imaging studies. Here, I review the new directions in which neoadjuvant treatments are evolving.

Today, treatments for metastatic breast cancers are tailored for specific subtypes. Starting with the introduction of the drug trastuzumab (Herceptin) for HER2-positive cancers, new, more specific treatment options were eventually developed and approved for other types as well. Estrogen deprivation endocrine therapies, lately prescribed in combination with CDK4/6 inhibitors, are used in estrogen receptor (ER)-positive cancers. Triple negative cancers (TNBC) are still treated mostly with chemotherapy, but immune checkpoint drugs and PARP inhibitors are explored in clinical trials, with some successes reported.

However, neoadjuvant treatments (except for HER2+ cancers) remain largely limited to chemotherapy regimens. This is starting to change now, with new approaches tailored to the cancer type being investigated in clinical trials.

In this regard, it is important to mention the I-SPY2 trial, NCT01042379, which started in 2010 and is for women with stage II-III breast cancer. It offers about a dozen drugs that are chosen based on particular features of the newly diagnosed cancers. This trial has a unique design and has produced some important results. Additional treatments and trials for various types of breast cancer are discussed below. Continue reading…


Immunotherapy Combination Safe and 62 Percent Effective in Metastatic Melanoma Patients

Excerpt:

“Immunotherapy is a promising approach in the treatment of metastatic melanoma, an aggressive and deadly form of skin cancer; but for most patients, immunotherapy drugs so far have failed to live up to their promise and provide little or no benefit. In a phase 1b clinical trial with 21 patients, researchers tested the safety and efficacy of combining the immunotherapy drug pembrolizumab with an oncolytic virus called T-VEC. The results suggest that this combination treatment, which had a 62% response rate, may work better than using either therapy on its own. The study appears September 7 in the journal Cell.”

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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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Wolchok Discusses T-VEC, Other Immunotherapy Developments in Melanoma

Excerpt:

“Melanoma research is rapidly advancing, particularly with immunotherapy, explains Jedd D. Wolchok, MD, PhD.

“ ‘With immunotherapy, we have come an extremely long way in the treatment of melanoma,’ says Wolchok, the Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation, chief, Melanoma and Immunotherapeutics Service, associate director, Ludwig Center for Cancer Immunotherapy, Memorial Sloan Kettering Cancer Center.

“Combination trials with immunotherapies offer great promise, he says. Recently, the combination of talimogene laherparepvec (T-VEC; Imlygic) and ipilimumab (Yervoy) in patients with advanced melanoma demonstrated an objective response rate of 50% in a single-arm phase Ib trial after a median follow-up time of 20 months. Forty-four percent of patients had a durable response lasting more than 6 months; after 18 months, progression-free survival (PFS) was 50% and overall survival was 67%.”

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Melanoma: New Drugs and New Challenges (Part 2 of 2)


Editor’s note: This is part 2 of a 2-part post on the latest research in melanoma. To learn about research into drug combinations for melanoma that may work better than single drugs, check out Melanoma: New Drugs and New Challenges (Part 1 of 2).

As always, the more new treatments become available in melanoma, the more new challenges arise. With eight new drugs approved for melanoma in the last five years, oncologists may sometimes face the difficult choice of what drugs to choose for a patient’s first-line treatment. Immune checkpoint drugs sometimes cause serious side effects, but progress is being made on how to treat these and also how to treat patients with pre-existing autoimmune conditions. New approaches are needed in efforts to prevent recurrence of melanomas diagnosed at earlier stages of disease progression. These and other challenges are discussed below. Continue reading…


Ipilimumab plus T-VEC Shows Promise for Metastatic Melanoma

Excerpt:

“Talimogene laherparepvec plus ipilimumab demonstrated safety and efficacy among patients with untreated, unresectable advanced melanoma, according to study results published in Journal of Clinical Oncology.

“ ‘Tumor immunotherapy has become an established treatment of metastatic melanoma and is being increasingly applied to other cancer types,’ Igor Puzanov, MD, MSCI, associate professor of medicine at Vanderbilt University School of Medicine, and colleagues wrote. ‘A hallmark of tumors likely to respond to immunotherapy is a lymphocyte-predominant tumor microenvironment. To date, immunotherapy designed to promote lymphocyte accumulation within established tumors, activate lymphocyte function and cytotoxicity, and prevent T-cell suppression has shown the most promise.’ ”

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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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