“U.S. regulators have expanded use of AstraZeneca’s lung cancer drug Tagrisso to include initial treatment of patients with a specific genetic mutation, the company said on Wednesday.
“The latest Food and Drug Administration approval includes patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
“Tagrisso, also known as osimertinib, was already approved for use in patients whose lung cancer worsened after treatment with other EGFR therapies and who have developed a secondary mutation.”
“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.”
“In a groundbreaking development, results from a recent clinical trial to treat lung cancer show that a novel immunotherapy combination is surprisingly effective at controlling the disease’s progression. The study, published April 4 in the journal The Lancet Oncology, focused on non-small cell lung cancer, which is the most common form of lung cancer.”
“Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.
“Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.”
“At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.
“Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.
“But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”
“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the combination of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) helped people with advanced non-squamous non-small cell lung cancer (NSCLC) live significantly longer compared with Avastin plus carboplatin and paclitaxel. A survival benefit was observed across key subgroups, including those with varying levels of PD-L1 expression. Safety for the TECENTRIQ and Avastin plus carboplatin and paclitaxel combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combinations. These data will be presented at an upcoming oncology congress.”
“A combination of Roche AG’s immunotherapy Tecentriq with two older cancer drugs bested chemotherapy in extending progression-free survival (PFS) among previously untreated patients with squamous non-small cell lung cancer (NSCLC), the Swiss pharma announced March 20.
“Results from the Phase 3 study, known as IMpower 131, could position Tecentriq as the first checkpoint inhibitor to market for first-line treatment of squamous NSCLC, a subset that accounts for 25% to 30%of all NSCLC cases.
“Roche only disclosed topline results for the combination regimen’s effect on PFS. At this point, no benefit in overall survival (OS) between the treatment and control groups was reported, but the study will continue to allow for further observation.”
“Immune checkpoint inhibitors have revolutionized the treatment of metastatic non-small cell lung cancer (NSCLC). In patients progressing on first-line therapy, immunotherapy with the PD-1/PD-L1 inhibitors pembrolizumab, nivolumab, and atezolizumab has become standard second-line therapy. While these agents are associated with durable responses and long-term improvements in overall survival (OS), only a small proportion of patients respond to treatment. Relatively little is known about the factors that predispose patients to response on checkpoint inhibitors, and there is an unmet need for improved patient selection criteria.”
“The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations. The news is a boost for companies like Foundation Medicine and Thermo Fisher Scientific, who are among the few firms with such tests on the market.
“Late Friday, the CMS said that, going forward, it will start to reimburse for tests that use DNA sequencing technology to map the tumors of patients with advanced cancers once approved by the FDA. Two of the already-approved tests fitting this description are FoundationOne CDx, from Cambridge, MA-based Foundation, and Oncomine Dx Target Test, from Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO). FoundationOne CDx looks for 324 cancer-related alterations in patients’ DNA. Foundation amasses a report based on the results and sends it to doctors, who use the data to suggest possible treatments. Oncomine detects 23 genetic alterations associated with non-small cell lung cancer.”