Gradalis®, Inc. Announces Dosing of First Patient in Pilot Study Combining Vigil® Engineered Autologous Tumor Cell Immunotherapy and Durvalumab in Advanced Breast Cancer

Excerpt:

“Gradalis®, Inc., a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a pilot study combining Vigil® Engineered Autologous Tumor Cells (EATCs) with durvalumab in advanced breast cancer. This is an open-label, investigator-sponsored study supported partly by a grant from Gradalis, to evaluate the safety, tolerability, and efficacy of the combination of Vigil engineered autologous tumor cell immunotherapy and durvalumab (an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1)) in patients with no PD-L1 expression and locally advanced or metastatic triple negative breast cancer (TNBC), that have progressed following two prior lines of therapy.”

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Is Keytruda Better than Opdivo?

Excerpt:

“Recent clinical trial results are likely to lead doctors to treat more patients who have a common form of lung cancer with a Merck drug at the expense of a Bristol-Myers Squibb medication at least until more data emerges, oncologists and analysts say.

“The yet-to-be-published studies involve drugs in a new class designed to enable the body’s immune system to fight cancer.

“A recent trial of Merck’s Keytruda (pembrolizumab) showed that it worked better than chemotherapy as an initial treatment for advanced non-small cell lung cancer (NSCLC) in patients with high levels of the PDL1 protein, believed to help identify those most likely to benefit from this type of immunotherapy.”

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Nivolumab/Ipilimumab Frontline Response Nears 60% in PD-L1+ NSCLC

Excerpt:

“Upfront treatment with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated an objective response rate (ORR) of 57% in patients with PD-L1-positive advanced non–small cell lung cancer (NSCLC), according to updated pooled findings from the phase Ib CheckMate-012 study presented at the 2016 ASCO Annual Meeting.

“In the 3-arm study, patients received nivolumab alone or in combination with ipilimumab every 6 weeks (Q6W) or every 12 weeks (Q12W). Across the full population, which was not selected based on PD-L1 expression, single-agent nivolumab had an ORR of 23%. In the combination arms, the ORRs were 47% and 39%, in the Q12W and Q6W arms, respectively.”

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FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer

Excerpt:

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.

“ ‘In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.’ ”

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Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) in Combination with Yervoy® (ipilimumab) for Treatment of Advanced Melanoma

Excerpt:

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults. The CHMP also added an informative statement to the broad indication that relative to Opdivo monotherapy, an increase in progression-free survival (PFS) for the combination of Opdivo with Yervoy is established only in patients with low tumor PD-L1 expression. This CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Opdivo monotherapy is already approved by the EC for advanced melanoma and previously treated advanced squamous non-small cell lung cancer (NSCLC), and was recommended for approval by the CHMP in February for previously treated advanced or metastatic non-squamous NSCLC and renal cell carcinoma (RCC).”

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Putting Immune Checkpoint Blockade to the Test in Breast Cancer


About 10 months ago, we asked: Is There a Future for Immunotherapy in Breast Cancer? Now, we can answer this question with a qualified “yes.” The data show why:

Triple-negative breast cancer (TNBC)

TNBC has long been considered to be more amenable to immune system-based treatments than other types of breast cancer because it is more immunogenic; that is, relatively high levels of immune cells accumulate within or adjacent to TNBC tumors. These immune cells could be triggered to attack tumors if properly activated. TNBC tumors are also likely to have a higher mutational burden (number of genetic mutations). This is one of the predictors of sensitivity to a type of treatment called immune checkpoint blockade.  Drugs known as checkpoint inhibitors block the proteins PD-1 or PD-L1. In cancer, PD-L1 proteins on tumor cells bind to PD-1 proteins on immune T cells and inhibit their tumor-killing activity. Immune checkpoint drugs disable this interaction and enable activation of T cells. These drugs are actively being explored in TNBC in clinical trials.

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Immune Therapy Drug Results in Prolonged Survival in Advanced Lung Cancer

“A Yale-led international study in patients with advanced non-small cell lung (NSCLC) cancer resistant to chemotherapy has found a promising weapon in an immune therapy drug commonly used to treat other cancers. The findings were published Dec. 19 in The Lancet and presented at the 2015 annual conference of the European Society for Medical Oncology in Singapore.

“The study, called KEYNOTE 010, compared pembrolizumab with the   docetaxel in 1,034 patients with NSCLC whose tumors expressed the PD-L1 biomarker. PD-L1 is a protein expressed by many tumor types that can render the  invulnerable to immune attack. The study endpoints were overall survival (OS), progression-free survival (PFS), and safety.”


Durvalumab/Tremelimumab Combo Could Be Useful in First-Line Treatment for NSCLC

“A combination of the anti–PD-L1 immune checkpoint inhibitor durvalumab (MEDI4736) with the anti–CTLA-4 monoclonal antibody tremelimumab showed improved tumor response in patients with advanced non–small cell lung cancer (NSCLC) over single-agent therapy.

“The study, published in the Journal for ImmunoTherapy of Cancer, was a phase I, open-label, dose-escalation/expansion study that contained 84 patients. Of these patients, 48 had two or more prior lines of therapy. Data from the study showed improved tumor response regardless of PD-L1 status, with an overall response rate of 25% and 35% of PD-L1-negative patients receiving a response (0% tumor cell staining).”


Merck's Keytruda Extends Survival in Lung Cancer Study

“Merck & Co’s approved Keytruda lung cancer treatment provided superior overall survival to chemotherapy in a late-stage study of patients with advanced disease whose tumors produce a protein called PD-L1 associated with increased risk of the disease.

“The U.S. drugmaker on Monday said patients taking the approved 2 milligram dosage of Keytruda and those taking an experimental 10 milligram dose had longer overall survival compared with those taking docetaxel, a standard treatment for non small cell lung cancer (NSCLC), the most common form of lung cancer. Keytruda thereby met its main goal of the study.

“Patients whose tumors had especially high levels of PD-L1 also went longer without a progression of disease than those taking docetaxel, Merck said. Those whose tumors expressed PD-L1, but not at high levels, did not show such a statistically significant benefit in progression-free survival.”