Lorlatinib Highly Effective for Relapsed ALK or ROS1 Rearranged NSCLC

Excerpt:

“While several targeted therapies have emerged in recent years for treatment of non-small cell lung cancer (NSCLC) carrying the anaplastic lymphoma kinase (ALK) gene fusion, development of resistance to ALK inhibitors is an increasing problem. Furthermore, only one tyrosine kinase inhibitor (TKI), crizotinib, is currently approved for patients with ROS proto-oncogene 1 (ROS1) rearrangements. Lorlatinib, a novel, highly selective ALK and ROS1 targeting third-generation TKI has shown preclinical activity against known ALK resistance mutations and can penetrate the central nervous system (CNS), a common site of metastasis in ALK-positive or ROS1-positive NSCLC.”

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Tiny Ignyta’s Lung Cancer Drug Bested Pfizer’s. Probably. Will We Ever Know For Sure?

Excerpt:

“There should have been a drug to prolong Stuart Brown’s life. But when his first option failed him, it seemed there was nothing else to try.

“Then came a drug made by Ignyta Pharmaceuticals, a San Diego-based drugmaker, that shrank his tumors and has kept them in check for more than a year. Results of a 32-patient study of the drug, presented today at the World Conference on Lung Cancer in Yokohama, Japan, show a best case scenario: the medicine shrank tumors in 79% of patients and kept working for a median 28.6 months, about 10 months longer than the current drug, Pfizer’s Xalkori, did in separate clinical trials. Lung cancer doctors are impressed, and the results best what financial analysts say could be a best-case scenario for Ignyta’s stock, which has already increased 200% year-to-date.”

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Pfizer Presents Full Results From Phase 2 Study of Next-Generation Investigational Alk-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer

Excerpt:

“Pfizer Inc. (NYSE:PFE) today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated. Further, side effects were generally manageable and primarily mild to moderate in severity. The results [Abstract #OA 05.06] were presented by Professor Benjamin Solomon, lead investigator and medical oncologist at Peter MacCallum Cancer Centre, Melbourne, Australia, today during an oral session at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan. Pfizer will also present data from several other lung cancer clinical programs.”

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Guideline on Stage IV Non-Small-Cell Lung Cancer Therapy Updated

Excerpt:

“An update of the American Society of Clinical Oncology (ASCO) clinical practice guideline clarifies the role of immunotherapy in the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The update also provides new recommendations on the use of targeted therapies for patients with changes in tumor EGFRALK, and ROS1 genes.

” ‘Treatment for lung cancer has become increasingly more complex over the last several years. This guideline update provides oncologists the tools to choose therapies that are most likely to benefit their patients,’ said Nasser Hanna, MD, co-chair of the Expert Panel that developed the guideline update.”

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FDA Grants Lorlatinib Breakthrough Designation for NSCLC

Excerpt:

“The FDA has granted a breakthrough therapy designation to lorlatinib for use in patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have previously received 1 or more ALK inhibitors, according to Pfizer, the company developing the next-generation ALK/ROS1 tyrosine kinase inhibitor (TKI).

” ‘This regulatory designation recognizes the potential for lorlatinib to provide an important treatment option for patients with ALK-positive NSCLC whose cancers have progressed despite treatment,’ Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development, said in a release. ‘Pfizer’s rapid development of lorlatinib reflects a commitment to developing biomarker-driven therapies to meet the evolving needs of patients.’ ”

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Pfizer Presents Promising Data from Next Generation ALK/ROS1 Inhibitor in Advanced Non-Small Cell Lung Cancer

Excerpt:

“Pfizer Inc. (NYSE:PFE) today announced encouraging new data from a Phase 1/2 study of lorlatinib, the proposed generic name for PF-06463922, Pfizer’s investigational, next-generation ALK/ROS1 tyrosine kinase inhibitor. The study showed clinical response in patients with ALK-positive or ROS1-positive advanced non-small cell lung cancer (NSCLC), including patients with brain metastases. These data were presented today in an oral presentation at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“The results presented are from the dose escalation component of an ongoing Phase 1 study of patients with ALK-positive or ROS1-positive NSCLC, with or without brain metastases, who were treatment-naïve or had disease progression after at least one prior tyrosine kinase inhibitor (TKI). Among patients with ALK-positive metastatic NSCLC, the overall response rate (ORR) with lorlatinib was 46 percent, with three patients achieving complete responses and 16 patients achieving a partial response (95% CI: 31-63). The median progression free survival (PFS) was 11.4 months (95% CI: 3.4 – 16.6). The majority of patients had received two or more prior ALK TKIs. Additionally, lorlatinib showed the ability to decrease the size of brain metastases in patients with ALK-positive or ROS1-positive metastatic NSCLC.”

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Ignyta Announces Updated Data from Entrectinib Phase 1 Clinical Trials at the 2016 AACR Annual Meeting

Excerpt:

“Ignyta, Inc. (RXDX),a precision oncology biotechnology company, today announced that updated results of its Phase 1 clinical trials of entrectinib, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK, were presented in an oral plenary session at the 2016 Annual Meeting of the American Association for Cancer Research (AACR) in New Orleans, Louisiana.

“ ‘We continue to be excited by entrectinib’s ability to help patients with advanced cancer,’ said Jonathan Lim, M.D., Chairman and CEO of Ignyta. ‘With respect to efficacy, in the 25 patients in the Phase 1 trials who would meet the eligibility criteria for our Phase 2 clinical trial, we saw tumor regression in 20 patients, or 80%. Nineteen out of 24 patients with extracranial solid tumors had a confirmed RECIST response, representing a 79% overall response rate; and one patient with an astrocytoma had evidence of substantial tumor regression by volumetric measurement. These responses were observed in patients with each of NTRK, ROS1 and ALK rearrangements, and across six tumor histologies, including complete and/or durable responses in both primary and metastatic tumors of the central nervous system.’ ”

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Novel Entrectinib Trial Focuses on Gene Rearrangements Across Many Tumor Types

Excerpt:

“A decade ago, researchers believed molecular alterations occurred in only one or two cancer types. That way of thinking has changed, however, with the understanding that the same alterations, especially gene fusions, can occur across many different tumor types.

“As a result, researchers have designed a recently launched clinical study into entrectinib, a first-inclass inhibitor of tropomyosin receptor kinases (Trk), as a basket trial in which the drug can be evaluated simultaneously for activity against three gene alterations and multiple tumor types.

“STARTRK-2 (NCT02568267) is an open-label, phase II study in which patients with locally advanced or metastatic solid tumors are assigned to different baskets according to whether their tumors harbor rearrangements in one of three key genes—NTRK1/2/3, ROS1, or ALK.”

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FDA Grants Priority Review to Xalkori for New Indication in NSCLC

“The FDA granted priority review to a supplemental new drug application for crizotinib.

“Crizotinib (Xalkori, Pfizer) — a kinase inhibitor — already is approved for treatment of patients with metastatic ALK-positive non–small cell lung cancer.

“The supplemental application requests that the approval be expanded to allow crizotinib to be used for treatment of patients with metastatic ROS1-positive NSCLC. The FDA granted breakthrough therapy designation to crizotinib for this indication in April.

“ROS1 rearrangement occurs in an estimated 1% of NSCLC cases, according to a Pfizer-issued press release.”