Immunomedics’ Sacituzumab Govitecan (IMMU-132) Demonstrates Efficacy and Safety in Non-Small-Cell Lung Cancer Patients With Multiple Prior Treatments, Including Immuno-Oncology

Excerpt:

Immunomedics, Inc., (IMMU) today announced that sacituzumab govitecan (IMMU-132), its lead investigational antibody-drug conjugate (ADC), shrank tumors by 30% or more initially in 26% (12/46) of evaluable patients with metastatic non-small-cell lung cancer (NSCLC), with a later confirmed overall objective response rate (ORR) of 13%, in accordance with RECIST 1.1 criteria. For the patients with confirmed responses, the duration of response (DOR) was 9 months.

“Interim median progression-free survival (PFS) and overall survival (OS) were 3.9 months (95% confidence interval [CI]; 3.4, 6.9) and 10.5 months (95% CI; 5.8, 10.5), respectively. Significant tumor shrinkage and disease stabilization was observed in both adenocarcinoma and squamous cell carcinomas, the two major subtypes of NSCLC, and in patients who had failed previous anti-PD-1/PD-L1 therapy.”

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Dabrafenib Active in BRAF-Mutant Metastatic NSCLC

Excerpt:

“Planchard et al found that the BRAF kinase inhibitor dabrafenib (Tafinlar) produced responses in previously treated and untreated patients with BRAF-mutant metastatic non–small cell lung cancer (NSCLC), according to a phase II trial reported in The Lancet Oncology. Activating BRAF V600E mutations are found in approximately 1% to 2% of lung adenocarcinomas.”

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Anti-HER2 Agents Show Potential in NSCLC

“While targeting HER2 mutations is mainly associated with breast cancer, there could be therapeutic potential with anti-HER2 agents in non-small cell lung cancer (NSCLC). At this year’s International Lung Cancer Congress, Corey Langer, MD, discussed the potential for afatinib and neratinib—dual inhibitors of EGFR and HER2—in NSCLC, as well as the need for additional research, in order to truly comprehend HER2 targeted therapy in this particular setting.

“HER2 mutations occur in about 2% to 4% of patients with NSCLC, and for the most part, they are mutually exclusive with other molecular drivers (eg, EGFR, KRAS), according to Langer, director of Thoracic Oncology at the Abramson Cancer Center of the University of Pennsylvania. “Similar to EGFR and ALK, the HER2 mutations are more common in women, never-smokers, and adenocarcinoma histology,” Langer added.

“Regarding use of afatinib in these patients, Langer said, ‘There are limited but encouraging data in patients with HER2-mutant NSCLC treated with either afatinib or afatinib plus paclitaxel.’ “


Drugs That Work in Melanomas with BRAF Mutation Also Work in Lung Cancers with Same Mutation

“A subset of lung cancer patients can derive important clinical benefits from drugs that are more commonly used to treat melanoma, the authors of a new academic clinical trial in Europe have reported at the European Lung Cancer Conference (ELCC) in Geneva, Switzerland.

“Dr. Oliver Gautschi, a medical oncologist from Lucern Cantonal Hospital in Switzerland, presented the results of the retrospective EURAF cohort study, which included lung cancer patients whose tumours carried specific mutations in the BRAF gene. The study was conducted by a network of European oncologists, without company involvement.

“BRAF mutations are commonly seen in melanoma patients, and are found in about 2% of lung adenocarcinomas, Gautschi explains. Several inhibitors of the B-Raf protein, including vemurafenib and dabrafenib, have been developed for use in melanoma patients, however there is currently no approved drug for BRAF-mutant lung cancer.

“As a result, experience with B-Raf inhibitors in lung cancer remains limited. ‘In the current study, we wanted to find out how many patients in Europe received B-Raf inhibitors outside of a clinical trial, and what their outcomes were,’ Gautschi says.

“The EURAF study gathered information on 35 lung cancer patients who had been identified as carrying BRAF mutations, who were treated with B-Raf inhibitors between 2012 and 2014.”


Crizotinib Is Highly Active in Lung Cancer with ROS1 Abnormality

“In a retrospective study in the European EUROS1 cohort reported in the Journal of Clinical Oncology, Mazières found that crizotinib (Xalkori) treatment was associated with an 80% response rate in patients with stage IV lung adenocarcinoma with ROS1 rearrangement.

“The study involved 31 patients who received crizotinib therapy through individual off-label use. Patients had a median age of 50.5 years, 64.5% were women, and 67.7% were never-smokers. Patients had received zero (n = 1), one (n = 9), two (n = 5), three (n = 3), or more than three (n = 13) lines of chemotherapy before crizotinib.

“Among 30 patients evaluated for response, 24 (80.0%) had objective response, including complete response in 5; 2 had stable disease (disease control rate of 86.7%); and 4 had disease progression. Median progression-free survival was 9.1 months, and 12-month progression-free survival was 44%. No unexpected adverse effects were observed…

“The investigators concluded: ‘Crizotinib was highly active at treating lung cancer in patients with a ROS1 rearrangement, suggesting that patients with lung adenocarcinomas should be tested for ROS1. Prospective clinical trials with crizotinib and other ROS1 inhibitors are ongoing or planned.’ ”


ASCO Endorses Lung Cancer Guidelines for Molecular Testing

Editor’s note: We previously posted another version of this story.

“The American Society of Clinical Oncology (ASCO) has endorsed a clinical practice guideline from several other professional associations aimed at guiding decisions on when to offer molecular testing for epidermal growth factor (EGFR) and anaplastic lymphoma kinase (ALK) mutations in patients with non–small-cell lung cancer (NSCLC). Research on drugs targeting some of these mutations has exploded in recent years, and clinicians in practice may have had trouble keeping up with when exactly testing should be done in order to guide use of those new therapies.

“ ‘This guideline is incredibly important, as it increases the ability to personalize lung cancer care and improve outcomes for patients with advanced lung cancer,’ said Natasha B. Leighl, MD, co-chair of ASCO’s panel that endorsed the new guideline, in a press release. ‘It describes the current evidence and helps oncologists and pathologists understand and put molecular testing into clinical practice.’

“The guideline is a joint product of the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. It contains 37 distinct recommendations, opinions, or suggestions, focusing on when to test for EGFR and ALK mutations; it was published on October 13 online in the Journal of Clinical Oncology.

“The primary recommendation is to offer EGFR and ALK testing to all patients with lung adenocarcinoma (or mixed lung cancers with an adenocarcinoma component), regardless of characteristics such as smoking status, gender, or race. Small tumor samples of other histologies could be considered for testing, particularly if ‘clinical criteria are suggestive’—this would include younger age, and a lack of smoking history, among other factors.”


ASCO: Offer EGFR, ALK Testing to All Patients with Lung Adenocarcinoma

The gist: For certain types of cancer, oncologists might use molecular testing to help figure out a patient’s treatment options. Molecular testing can uncover certain genetic mutations that might make a tumor treat-able with certain kinds of drugs. Many patients with lung adenocarcinomas are already tested for EGFR mutations; a person with an EGFR mutation could be treated with an “EGFR inhibitor” drug, such as erlotinib (aka Tarceva). Now, a new guideline states that all patients with lung adenocarcinoma should be tested for both EGFR mutations and a mutation known as ALK rearrangement. Testing for these two mutations could show which patients could benefit from which targeted therapy drugs.

“ASCO today endorsed a joint clinical practice guideline from three other entities that addresses questions about the appropriate use of EGFR-mutation and ALK-rearrangement testing in patients with lung cancer.

“A key recommendation from the guideline — developed by the College of American Pathologists, the International Association for the Study of Lung Cancer and the Association for Molecular Pathology — states that clinicians should offer EGFR and ALK testing to all patients with lung adenocarcinoma, as well as those with mixed lung cancer with an adenocarcinoma component.

“The testing should be offered regardless of characteristics — such as smoking status, gender and race — to help determine which patients could benefit from targeted therapy with tyrosine kinase inhibitors, according to the guideline.

“ ‘This guideline is incredibly important, as it increases the ability to personalize lung cancer care and improve outcomes for patients with advanced lung cancer,’ Natasha B. Leighl, MD, MSc, medical oncologist at Princess Margaret Hospital in Toronto and co-chair of the ASCO expert panel that reviewed and endorsed the guideline, said in a press release. ‘It describes the current evidence and helps oncologists and pathologists understand and put molecular testing into clinical practice.’

“Patients with advanced-stage disease should be offered testing at the time of diagnosis, and patients with lower-stage disease should undergo testing at the time of progression or recurrence, the guideline states.”


ALCHEMIST Aims to Curtail Return of Early-Stage Lung Cancer


A series of three new clinical trials (research studies with volunteer patients) is big news for some people affected by early-stage lung cancer. The trials focus on two drugs typically used to treat late-stage adenocarcinoma. These two drugs, Tarceva and Xalkori, may also help stage I, II, and IIIA patients prevent relapse (return of cancer) after their tumors have been surgically removed. The new clinical trials will put the treatments to the test. Continue reading…


Ros1 Gene Fusions Found in 2.4% of Asian Patients with Lung Adenocarcinoma, Associated with Young Age at Diagnosis

The gist: Oncologists can sometimes look for certain genetic mutations in a patient’s tumor to help determine the best treatment options for that patient. Researchers have recently found that a particular mutation called ROS1 fusion is present in a subgroup of patients consisting of young East Asian patients with lung adenocarcinoma. People with ROS1 mutations in their lung tumors might benefit from treatment with a drug called crizotinib. The drug has not yet been approved for widespread use by the U.S. Food and Drug Administration (FDA), but patients can enroll in clinical trials to gain access to it.

“ROS1 fusion genes were successfully detected independent of gender or smoking history in young East Asian patients with lung adenocarcinoma, a histological subgroup in non-small cell lung cancer (NSCLC), using multiplex reverse transcriptase-polymerase chain reaction (RT-PCR) and immunohistochemistry (IHC) diagnostic tests.

“In NSCLC treatment algorithms, a personalized therapy approach is now being taken based on the genetic characteristics of the cancer. Patients with specific oncogenic molecular aberrations, for example EGFR mutations and ALK gene fusions, respond well to drugs that target these molecular abnormalities. ROS1 is another potential oncogenic molecular driver and this target is sensitive to crizotinib, a drug approved for the treatment of ALK gene fusion NSCLC .

“Researchers from the National Taiwan University Hospital examined 160 surgical specimens from early-stage and 332 specimens of fluid around the lungs (malignant pleural effusions) from late-stage lung adenocarcinoma patients. They initially examined these specimens for EGFR and KRAS mutations as well as ALK gene. Specimens that were negative for these three oncogenic drivers were then examined for ROS1 fusions using RT-PCR and IHC. Fluorescence in situ hybridization (FISH) was used if there was a discrepancy between RT-PCR and IHC.”