IMFINZI® after Chemoradiotherapy Significantly Improves Overall Survival in Stage III NSCLC

November 8th, 2018

IMFINZI® (Durvalumab) is a selective, high-affinity, human IgG1 monoclonal antibody, that blocks the binding of Programmed Death Ligand 1 (PD-L1) to Programmed Death 1 (PD-1) receptor and CD80, thereby unleashing the T cells to recognize and kill tumor cells. Patients with stage III Non Small Cell Lung Cancer (NSCLC) are often treated with platinum-based doublet chemotherapy with concurrent radiation and have a median Progression Free Survival (PFS) of approximately 8 months and 5 year survival of only 15%. PACIFIC trial is a randomized, double-blind, international, phase III study in which IMFINZI® as consolidation therapy was compared with placebo, in patients with stage III, locally advanced, unresectable NSCLC, that had not progressed following platinum-based chemoradiotherapy.
At a median follow up of 25.2 months, the 24-month Overall Survival rate was 66.3% in the IMFINZI® group and 55.6% in the placebo group, suggesting a significantly prolonged Overall Survival with IMFINZI® when compared with placebo and a 32% reduction in the risk of death (HR for death=0.68; P=0.0025). The Overall Survival benefit with IMFINZI®, was observed across all the prespecified subgroups.
PACIFIC trial is the first study to demonstrate a survival advantage for unresectable Stage III NSCLC, supporting this regimen as the standard of care.


MicroRNA-31-3p Expression is a Predictive Biomarker of Anti-EGFR Efficacy in Patients with RAS Wild-type Metastatic Colorectal Cancer

October 9th, 2018

Advanced ColoRectal Cancer (CRC) is often incurable and standard chemotherapy when combined with anti EGFR (Epidermal Growth Factor Receptor) targeted monoclonal antibodies such as VECTIBIX® (Panitumumab) and ERBITUX® (Cetuximab) as well as anti VEGF agent AVASTIN® (Bevacizumab), have demonstrated improvement in Progression Free Survival (PFS) and Overall Survival (OS). The benefit with anti EGFR agents however is only demonstrable in patients with metastatic CRC, whose tumors do not harbor RAS mutations. It is now becoming clear that among these pan RAS wild type tumors, a predictive biomarker, MiR-31-3p expression in tumors, may further determine who would benefit from Anti-EGFR targeted therapy.
In a recently published study (Clin Cancer Res 2018), tumors with Low MiR-31-3p expression benefited from ERBITUX® combination compared to AVASTIN® for PFS (HR=0.74;P=0.05), OS (HR=0.61;P<0.01) and Objective Response Rate (P<0.01). There was however no difference in outcomes among High MiR-31-3p expressors between the two treatment groups. This study suggested that only low MiR-31-3p expressing tumors among the pan RAS wild type CRC patients benefit from Anti-EGFR targeted therapies.


American Cancer Society Updates Colorectal Cancer Screening Guideline for Average Risk Adults

September 17th, 2018

The ACS recently updated Colorectal Cancer Screening Guideline using prevailing evidence as well as microsimulation modeling analyses. The new guideline does not prioritize among screening test options. This is because test preferences vary among individuals and the guidelines development committee emphasized that screening rates could be improved by endorsing the full range of tests without preference. Adults born around 1990 have twice the risk of colon cancer and four times the risk of rectal cancer compared with adults born around 1950, who have the lowest risk. In the updated guideline, screening is recommended earlier, starting at age 45 years and may be performed  with either a high-sensitivity stool-based test or a structural (visual) exam, depending on patient preference and test availability.


First Line TECENTRIQ® plus Chemotherapy in Advanced Squamous NSCLC

July 30th, 2018

Non Small Cell Lung Cancer (NSCLC) accounts for approximately 85% of all lung cancers and 30% are Squamous Cell Carcinomas (SCC). Non Small Cell Lung Cancer patients with Squamous Cell histology have been a traditionally hard- to-treat, patient group, and less than 15% of patients with advanced Squamous NSCLC survive a year after diagnosis and less than 5% of patients survive for five years or longer. IMpower131 is a multicenter, open-label, phase III study, in which 1021 chemotherapy-naïve patients with stage IV Squamous NSCLC received TECENTRIQ® ((Atezolizumab)) along with Carboplatin, and Paclitaxel, TECENTRIQ® along with Carboplatin, and ABRAXANE® (nab-paclitaxel) or Carboplatin and ABRAXANE® (control group). The addition of  TECENTRIQ® to chemotherapy significantly improved median Progression Free Survival across all PD-L1 subgroups. This is the first phase III trial of an immunotherapy-based treatment regimen, to demonstrate a significant improvement in Progression Free Survival, in advanced Squamous NSCLC.


MRI Targeted Biopsy Superior to Standard TRUS Guided Biopsy for Prostate Cancer Diagnosis

June 12th, 2018

TransRectal UltraSound (TRUS) guided biopsy has been the standard of care for diagnosing prostate cancer in men with a clinical suspicion of prostate cancer. TRUS guided biopsy is a blind biopsy of the lateral and posterior peripheral zone of the prostate using a template, and 10 to 12 cores of prostate tissue is obtained. Even though this may result in a higher rate of prostate cancer detection, many detected are low grade tumors that do not benefit from treatment. The major limitation of this biopsy procedure is the risk of under-sampling a more significant tumor that is located in a region of the prostate not usually targeted with a template.
Multiparametric MRI (mp-MRI) combines anatomic imaging in the form of T2-weighted imaging, with functional imaging, and is being used to detect or rule out cancer in men who have persistent concern for prostate cancer. It can be used as a triage test to avoid a biopsy if the results were negative, and if positive could be used for targeting abnormal areas in the prostate during biopsy. In the PRECISION study, mp-MRI was superior to standard TRUS guided biopsy, and was able to identify a high proportion of men who would benefit from treatment, and minimizes the identification of men with clinically insignificant cancer, thereby preventing overtreatment. Utilizing mp-MRI, more than 25% of the participants in this study were able to avoid a biopsy.


FDA Approves AndexXa®, The First Antidote for Factor Xa Inhibitors

May 13th, 2018

The FDA on May 3, 2018 approved AndexXa&reg; (Andexanet Alfa), a recombinant coagulation Factor Xa, inactivated-zhzo), for patients treated with XARELTO&reg; (Rivaroxaban) and ELIQUIS&reg; (Apixaban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval of AndexXa&reg; was based on data from two Phase III ANNEXA studies (ANNEXA-A and ANNEXA-R) as well as interim data from the ongoing ANNEXA-4 study. AndexXa&reg; significantly reduced anti-Factor Xa activity of Factor Xa Inhibitors by over 90% compared with placebo, with reversal persisting for 1 to 2 hours after completion of the infusion. The availability of this antidote assures both patients and Health Care Providers to consider Factor Xa inhibitors with greater confidence.


Larotrectinib – A Novel Age and Tumor Agnostic Therapy for TRK Fusion-Positive Cancers

March 20th, 2018

Tumor genomic profiling enables the identification of specific genomic alterations and thereby can provide personalized treatment options with targeted therapies that are specific for those molecular targets. Next-Generation Sequencing (NGS) platforms or second-generation sequencing perform massively parallel sequencing, which allows sequencing of millions of fragments of DNA from a single sample. Recently reported genomic profiling studies performed in patients with advanced cancer suggest that actionable mutations are found in 20-40% of patients’ tumors.
Larotrectinib is a potent and highly selective small molecule inhibitor of three TRK proteins, Tropomyosin Receptor Kinase genes NTRK1, NTRK2, and NTRK3. In a phase I-II study involving children, adolescents and adults with 17 unique cancer diagnoses, the Overall Response Rate was 75% and at 1 year, 71% of the responses were ongoing and 55% of the patients remained progression-free. It was concluded from this study that TRK fusions defined a unique molecular subgroup of advanced solid tumors in children and adults and Larotrectinib had marked and durable antitumor activity in patients with TRK fusion-positive cancer, regardless of the age of the patient or tumor type.


FDA Approves ZYTIGA® for High-Risk Metastatic Castration-Sensitive Prostate Cancer

March 1st, 2018

The FDA on February 7, 2018, approved ZYTIGA® (Abiraterone acetate) in combination with Prednisone for metastatic high-risk Castration Sensitive Prostate Cancer (CSPC). The FDA initially approved ZYTIGA® with prednisone in 2011 for patients with metastatic Castration Resistant Prostate Cancer (CRPC), who had received prior chemotherapy, and the FDA expanded the indication in 2012, for patients with chemo naïve metastatic CRPC. The addition of ZYTIGA® along with Prednisone, to Androgen Deprivation Therapy, significantly increased Overall Survival and radiographic Progression Free Survival, in men with newly diagnosed, metastatic, Castration Sensitive Prostate Cancer. The new approval will change the treatment landscape for patients with metastatic CSPC.


Guideline for Human Papilloma Virus Testing in Head and Neck Carcinomas

February 9th, 2018

The Centers for Disease Control and Prevention estimates that in the US, there are more than 16,000 cases of Human PapillomaVirus (HPV)-positive OroPharyngeal Squamous Cell Carcinoma (OPSCC) per year and there has been a significant increase in incidence during the past several decades. Expression of tumor suppressor protein, known as p16, is highly correlated with infection with HPV in HNSCC. Accurate HPV assessment in head and neck cancers is becoming important as it significantly impacts clinical management. The College of American Pathologists convened a panel of experts and following review of evidence from over 400 peer reviewed articles, came up with the Guideline. This can be reviewed at www.oncoprescribe.com.  This guideline is recommended for all new Oropharyngeal Squamous cell carcinoma patients, but not routinely recommended for other head and neck carcinomas.


FDA Approves OPDIVO® for Adjuvant Treatment of Malignant Melanoma

January 14th, 2018

The FDA on December 20, 2017, granted regular approval to the anti-PD1 monoclonal antibody, OPDIVO® (Nivolumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. The approved adjuvant therapies over the past two decades, for patients with high-risk melanoma have included high-dose INTRON® A (Interferon alfa-2b), SYLATRON® (peginterferon alfa-2b), and high-dose YERVOY® (Ipilimumab). The significant toxicities associated with these adjuvant interventions, precluded the wide spread use of adjuvant therapy in high risk melanoma.

OPDIVO® is a less toxic, better tolerated, adjuvant treatment option than YERVOY®, for patients with resected stage IIIB/C and IV melanoma, regardless of BRAF mutation. The Recurrence Free Survival rate at 18 months with OPDIVO® was 66.4% compared with 52.7% for YERVOY® and this meant a 35% reduction in the risk of recurrence or death with the OPDIVO® versus YERVOY®.  This will fulfill the unmet need  for adjuvant therapies, with improved benefit-risk ratio, for this patient group.