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


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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US Widens Use of Boehringer's Lung Cancer Drug Gilotrif


“US health officials have expanded the approved indications for Boehringer Ingelheim’s Gilotrif, clearing its use in patients with squamous cell carcinoma of the lung.

“Gilotrif (afatinib), an oral, once-daily EGFR-directed therapy, is currently cleared in the US for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.

“Approval for squamous cell carcinoma of the lung, a disease linked with a particularly bleak poor prognosis of one-year survival post diagnosis, was based on data from the head-to-head LUX-Lung 8 trial in patients whose tumours progressed after first-line chemotherapy.”

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Tumor Histology Is Factor in Determining Need for Lobectomy

“Limited resection is not equivalent to lobectomy when used to treat older patients with stage IA lung cancer of invasive cell types, namely invasive adenocarcinoma and squamous cell carcinoma, a population-based study has now determined.

“Instead, these patients may be considered for completion lobectomy or for adjuvant treatments, Rajwanth R. Veluswamy, MD, at Icahn School of Medicine at Mount Sinai, New York, NY, and colleagues report online in the Journal of Clinical Oncology.

” ‘Tumor histology in early-stage lung cancer is an important predictor of survival and has therapeutic implications,’ Veluswamy said in an interview. ‘Patients with relatively indolent tumors such as adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) have excellent survival following resection and are therefore likely to benefit from parenchymal sparing provided by limited surgical approaches.’ “

Afatinib Improves Progression-Free Survival vs Erlotinib in Second-Line Treatment of Advanced Squamous Cell Carcinoma of the Lung

“In the phase III LUX-Lung 8 trial reported in The Lancet Oncology, Soria et al found that the irreversible ErbB-family inhibitor afatinib (Gilotrif) significantly improved progression-free and overall survival vs the EGFR tyrosine kinase inhibitor erlotinib as second-line treatment in patients with stage IIIB or IV squamous cell carcinoma of the lung who had disease progression after four or more cycles of platinum-based chemotherapy.

“In this open-label trial, 795 patients from 23 countries were randomly assigned between March 2012 and January 2014 to receive afatinib at 40 mg/d (n =398) or erlotinib at 150 mg/d (n = 397). The primary endpoint was progression-free survival on independent central review in the intent-to-treat population…

“The investigators concluded: ‘The significant improvements in progression-free survival and overall survival with afatinib compared with erlotinib, along with a manageable safety profile and the convenience of oral administration suggest that afatinib could be an additional option for the treatment of patients with squamous cell carcinoma of the lung.’ “

Boehringer's Giotrif Beats Roche's Tarceva on Lung Cancer Survival

“Boehringer Ingelheim’s Giotrif has shown a greater survival benefit than Roche’s Tarceva in previously-treated patients with advanced squamous cell carcinoma of the lung.

“According to data from the LUX-Lung 8 trial, published in The Lancet Oncology, Giotrif (afatinib) extended overall survival to a median of 7.9 months compared to 6.8 months on Tarceva (erlotinib), reducing the risk of death by 19%.

“The study also met its primary endpoint showing a significant improvement in progression-free survival over Tarceva, which is an approved and recommended treatment option for advanced SCC of the lung following treatment with first-line platinum-based chemotherapy.”

Bristol Immunotherapy Shows Promise in Lung Cancer Trial

The gist: People with advanced squamous non-small cell lung cancer (NSCLC) that worsened despite two rounds of treatment might benefit from additional treatment with the new drug nivolumab, aka Opdivo. In a clinical trial with volunteer patients, 41% of the people who took nivolumab were still alive after one year. That’s much higher than the historical rate of one-year survival for these kinds of patients, which is between 5.5% to 18%. Nivolumab is an immunotherapy drug, meaning that it boosts a patient’s own immune system to fight cancer.

“Treatment of advanced squamous cell non-small cell lung cancer (NSCLC) with Bristol-Myers Squibb Co’s experimental immunotherapy nivolumab led to a one-year survival rate of 41 percent in a midstage clinical trial, according to data being presented at a medical meeting.

“While the study called CheckMate-063 did not compare nivolumab with another drug or placebo, the historical one-year survival rate for patients like those in the trial, whose cancer had progressed after treatment with two or more prior therapies, is between 5.5 percent and 18 percent, the company said.

“Nivolumab belongs to a highly promising new class of drugs called PD-1 inhibitors that block a tumor’s ability to camouflage itself, allowing the body’s immune system to recognize and attack the cancer. Merck & Co last month received the first U.S. approval of a drug from the class to treat advanced melanoma – the deadliest form of skin cancer.

“The Phase II findings from CheckMate-063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies,” Dr Suresh Ramalingam, director of Medical Oncology at Winship Cancer Institute of Emory University, said in a statement.”

Prognostic Factors Identified for Peripheral Squamous Cell Carcinomas of the Lung

The gist: Some people diagnosed with early-stage peripheral lung squamous cell carcinoma (p-SCC) might have lower chances of survival than others. Scientists have now uncovered new ways of predicting a p-SCC patient’s chances of survival. The scientists say that research should be done to see whether p-SCC patients with lower chances of survival might benefit from chemotherapy after tumor-removal surgery.

“Better survival outcome is associated with low blood levels of squamous cell carcinoma antigen, or absence of tumor invasion either into the space between the lungs and chest wall or into blood vessels of individuals with a peripheral squamous cell carcinoma, a type of non-small cell lung cancer (NSCLC).

“Lung cancer is the most common cause of cancer-related death worldwide and lung squamous cell carcinomas (SCC) account for 20-30% of all NSCLC. SCC can be classified as either central (c-SCC) or peripheral (p-SCC) depending on the primary location. While c-SCC is the most prevalent, the incidence of p-SCC is increasing and the clinical and biological behaviors of p-SCC remain unclear.

“Researchers from Keio University School of Medicine and Saiseikai Utsunomiya Hospital in Japan evaluated several clinical and pathological variables in 280 patients with surgically removed p-SCC in order to identify potential prognostic factors…

“The authors propose that ‘patients with high serum SCC levels, vascular invasion or pleural invasion should have their tumor stage upgraded in order to reflect the clear differences in survival. Clinical trials should be performed to evaluate if postoperative chemotherapy would benefit these patients who typically may not receive chemotherapy because of their early stage.’ “

NCI/FDA Lung Cancer Workshop Leads to the Innovatively Designed Clinical Trials

The gist: Clinical trials are research studies with volunteer patients. They are often used to test how safe and effective new cancer treatments are. Patients can enroll in them to gain access to new treatments. Recently, researchers launched two new clinical trials for lung cancer patients. (One of them, called ALCHEMIST, was recently covered by our Chief Scientist on our Need to Know blog.) Both trials aim to maximize benefit to patients and researchers alike through molecular testing and carefully matching patients with the treatments most likely to work for them. This is a relatively new approach to clinical trial design that may herald a widespread shift for the whole field of cancer research.

“The recent launch of two clinical trials offer innovative study designs for patients with lung cancer. These clinical trials are the direct result of a National Cancer Institute (NCI) sponsored workshop chaired by Drs. Fred R. Hirsch, Shakun Malik and Claudio Dansky- Ullman, that brought together the NCI Thoracic Malignancies Steering Committee, the US Food and Drug Administration (FDA), academicians, clinicians as well as industry and government stakeholders to discuss issues and challenges related to clinical trial design and biomarkers for lung cancer targeted-therapies.

“The purpose of the NCI/FDA workshop was to collaboratively design a high priority biomarker-driven clinical trial that could expeditiously evaluate the clinical utility of a targeted-therapy in a molecularly defined lung cancer population and aid in data collection needed for regulatory approval. The workshop, whose consensus report appears in the October issue of the Journal of Thoracic Oncology, the official journal of the International Association for the Study of Lung Cancer (IASLC), discussed the types of biomarkers (prognostic vs predictive), the various clinical trial designs that can be employed with predictive biomarkers as well as primary endpoints for clinical trials. Also discussed were the regulatory challenges related to drug development, biomarker and biomarker assay development, trial design, and the amount of data needed for approval of both drugs and in vitro diagnostics. The attendees agreed that ‘in order to accelerate development of biomarker-driven trials it is critical to enhance coordination between pharmaceutical industries, FDA, academic and community-based clinical investigators, NCI, and patient organizations with the intention to enhance collaboration between these organizations, bring forward new drugs much more rapidly for approval and ultimately improving long-term outcomes for patients.’ “

A New Tool to Confront Lung Cancer

“Only 15% of patients with squamous cell lung cancer – the second most common lung cancer – survive five years past diagnosis. Little is understood about how the deadly disease arises, preventing development of targeted therapies that could serve as a second line of defense once standard chemotherapy regimens fail.

“Published online in Cell Reports on June 19, Huntsman Cancer Institute investigators report that misregulation of two genes, sox2 and lkb1, drives squamous cell lung cancer in mice. The discovery uncovers new treatment strategies, and provides a clinically relevant mouse model in which to test them.”

Editor’s note: Some tumors have specific genetic mutations that can allow them to be treated with drugs known as targeted therapies. Studying mice with squamous cell lung cancer tumors, scientists have now discovered two new tumor mutations that open up the possibility for new drugs to be developed for humans. The mutations also indicate that some drugs that already exist for other cancers may be used to treat people with squamous cell lung cancer. More investigation is required before the results of these findings might translate to treatments for patients.