Selective AXL Inhibitor Bemcentinib Meets Pre-specified Efficacy Endpoint in Stage 1 of NSCLC Phase II Combination Trial With KEYTRUDA

Excerpt:

“BerGenBio ASA (OSE:BGBIO) announces today that on a top-line, preliminary basis, the first efficacy endpoint has been met in its Phase II clinical trial (BGBC008) evaluating bemcentinib, a first-in-class oral selective AXL inhibitor, in combination with the Merck & Co., Inc., Kenilworth, N.J., USA[1] anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as a potential new treatment regimen for advanced non-small cell lung cancer (NSCLC). The primary efficacy endpoint requires at least four patients (out of the first 22 treated patients) to achieve clinical responses when treated with the novel drug combination, defined as either complete or partial response, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).”

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Immunotherapy Outcomes May Be Better in Older Patients With Melanoma

Excerpt:

“Older patients with melanoma may respond better to anti-PD-1 immunotherapy treatment than their younger counterparts, according to a recent study published in Clinical Cancer Research, a journal from the American Association for Cancer Research.

“Researchers collected melanoma tissue samples from 538 patients from the United States, Australia and Germany. The samples were then divided into two categories: those belonging to people over the age of 62 and those belonging to people younger than 62. All of the patients were treated with the immunotherapy agent, Keytruda (pembrolizumab), which targets and blocks PD-1, making the immune system more likely to identify and attack cancer cells.”

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Niraparib/Pembrolizumab Combo Active in Relapsed, Progressive TNBC

Excerpt:

“Half of patients with metastatic triple-negative breast cancer (TNBC) achieved disease control when treated with the combination of a poly (ADP-ribose) polymerase (PARP) inhibitor and an anti–PD-1 agent, a preliminary prospective study showed.

“Overall, 13 of 46 evaluable patients had objective responses to treatment with niraparib (Zejula) and pembrolizumab (Keytruda). An additional 10 patients had stable disease. Clinical activity was observed in patients beyond those with germline BRCA mutations.”

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Merck’s KEYTRUDA® (Pembrolizumab) Plus Pemetrexed (ALIMTA®) and Platinum Chemotherapy Reduced the Risk of Death by Half Compared with Chemotherapy Alone as First-Line Treatment for Advanced Nonsquamous NSCLC in Phase 3 KEYNOTE-189 Study

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA ® , Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Findings showed that the KEYTRUDA-pemetrexed-platinum chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by half compared with chemotherapy alone (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001). In pre-specified exploratory analyses, an OS benefit was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated, including: patients whose tumors were negative for PD-L1 (HR=0.59 [95% CI, 0.38-0.92]); patients whose tumors had PD-L1 tumor proportion scores (TPS) of 1-49 percent (HR=0.55 [95% CI, 0.34-0.90]); and patients who had a TPS of greater than or equal to 50 percent (HR=0.42 [95% CI, 0.26-0.68]). The addition of KEYTRUDA to pemetrexed plus platinum chemotherapy also achieved a significant improvement in progression-free survival (PFS), with a reduction in the risk of progression or death of nearly half for patients in the KEYTRUDA combination arm, compared with chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p<0.00001). A PFS improvement in the KEYTRUDA combination group was observed in patients whose tumors were negative for PD-L1 (HR=0.75 [95% CI, 0.53-1.05]); patients with a TPS of 1-49 percent (HR=0.55 [95% CI, 0.37-0.81]); and patients with a TPS greater than or equal to 50 percent (HR=0.36 [95% CI, 0.25-0.52]). These results are being presented today in a plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2018 (Abstract #CT075), with simultaneous publication in The New England Journal of Medicine.”

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Predicting If an Immune Checkpoint Drug Will Work


Drugs that activate the immune system to attack cancer in a process known as immune checkpoint blockade (ICB) are a focus of intense investigation. A number of them are already approved by the U.S. Food and Drug Administration (FDA) for various cancers; namely, the anti-CTLA4 antibody ipilimumab (Yervoy), two anti-PD-1 antibodies: pembrolizumab (Keytruda) and nivolumab (Opdivo), and three anti-PD-L1 drugs: atezolizumab (Tecentriq), avelumab (Bavencio) and durvalumab (Imfinzi). These ICB drugs have the potential to induce durable cancer regressions, but the majority of cancer patients just do not respond to them at all.

Biomarkers, signature molecules in the blood or other tissue, can sometimes be used to predict a patient’s response to a given treatment. But no reliable biomarkers exist for ICB, and this is a serious concern. Patients who may really benefit from ICB could be overlooked, and patients who are not likely to respond may receive useless (and very expensive) ICB treatment.

Most potential response predictors that have already been identified are not yet useful for one or all of the following reasons: they are not extensively validated, their significance is still uncertain and may differ from one cancer (or even one patient) to another, or they are technically challenging for routine use. These markers are addressed below. Continue reading…


Keytruda (Pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells

Excerpt:

“Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-042 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC, including nonsquamous or squamous histologies) met its primary endpoint of overall survival (OS). An interim analysis conducted by the independent Data Monitoring Committee (DMC) demonstrated that treatment with KEYTRUDA resulted in significantly longer OS than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent. As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of ≥50 percent, with a TPS of ≥20 percent and then in the entire study population with a TPS of ≥1 percent. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported monotherapy studies involving patients with advanced NSCLC.”

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First-Line Keytruda Plus Chemotherapy Improves OS, PFS in Non-Small Cell Lung Cancer

Excerpt:

“The addition of pembrolizumab to pemetrexed and cisplatin or carboplatin improved OS and PFS as first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer, according to a manufacturer-issued press release.

“Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — is indicated for the treatment of patients with unresectable or metastatic melanoma, in addition to the treatment of other cancer types.”

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Immunotherapy Continues Growth With Trials in mCRPC

Excerpt:

“Although modern immunotherapy has yet to have a breakthrough in prostate cancer to the degree it has had in lung cancer or urothelial carcinoma, combinations with anti–PD-1/PD-L1 agents are beginning to show promise for these patients in clinical trials.

“Currently ongoing is a phase II trial of durvalumab (Imfinzi) in combination with the PARP inhibitor olaparib (Lynparza) in patients with metastatic castration-resistant prostate cancer (mCRPC; NCT02484404). Investigators note that previous data have suggested that 25% to 30% of sporadic mCRPC has DNA-repair pathway defects. Results thus far have demonstrated that the synergy of durvalumab and olaparib proves that the combination may be a viable option for patients with mCRPC who are heavily pretreated. The trial is still accruing.”

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Does Gut Flora Impact the Response to Cancer Immunotherapy?

Excerpt:

“Gut microbes can help or hinder cancer patients’ response to immunotherapy, two new studies suggested.

“In 112 melanoma patients undergoing anti-PD-1 immunotherapy, those with a high diversity of gut microbes had not yet reached median progression-free survival (PFS) after nearly 2 years, because less than half of them had progressed, while median PFS in the low-diversity group was 188 days (hazard ratio 3.57, 95% CI 1.02-12.52, P<0.05), said Jennifer Wargo, MD, of the MD Anderson Cancer Center in Houston, and colleagues.”

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