Opdivo Alone or Combined with Yervoy Shows Encouraging Response and Survival Rates in Recurrent Small Cell Lung Cancer Patients with High Tumor Mutation Burden, in Exploratory Analysis from Phase 1/2 Study CheckMate -032

Excerpt:

Bristol-Myers Squibb Company (NYSE:BMY) today announced data evaluating Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) in previously treated small cell lung cancer (SCLC) patients whose tumors were evaluable for tumor mutation burden (TMB), from the Phase 1/2 CheckMate -032 trial. The primary objective of this trial was objective response rate (ORR) as assessed by a blinded independent central review (BICR), for which results were previously presented; in the pooled intent-to-treat (ITT) population (n=401), the ORR was 11% with Opdivo alone and 22% with the combination. Among the ITT population, 211 (53%) patients had an evaluable TMB result for these analyses and were divided into subgroups of high, medium and low levels of TMB.”

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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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Combination of Optune® with Temozolomide Demonstrates Unprecedented Five-Year Survival for Newly Diagnosed Glioblastoma Patients

Excerpt:

“Novocure (NVCR) announced today results from its phase 3 pivotal EF-14 trial adding Optune to temozolomide for the treatment of newly diagnosed glioblastoma (GBM), including results from health-related quality of life analyses, were presented at the American Society for Radiation Oncology’s (ASTRO) 2017 Annual Meeting in San Diego. This marks the first presentation of EF-14 five-year survival and quality of life data at a radiation oncology conference.

“A late-breaking oral presentation focused on Novocure’s EF-14 phase 3 pivotal trial, which demonstrated unprecedented five-year survival results in newly diagnosed GBM. Patients treated with Optune in combination with temozolomide experienced a significant extension of overall survival without added toxicity compared to patients treated with temozolomide alone. The data also showed that Optune-treated patients were able to maintain quality of life for longer compared to patients treated with temozolomide alone.”

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In Breast Cancer, a Victory for Common Sense

Excerpt:

“New 10-year results from a major clinical trial in breast cancer confirm that it does not compromise overall survival to leave behind minimal amounts of cancer that have spread to the underarm lymph nodes in certain patients, according to the investigators.

“The long-term data are from the American College of Surgeons Oncology Group Z0011 trial and were published online September 12 in JAMA.

“The study participants were women with clinical T1 or T2 invasive breast cancer, no palpable axillary nodes, and 1 or 2 sentinel lymph nodes containing metastases. In addition to lymph node management, all patients were treated with lumpectomy, tangential whole-breast irradiation, and adjuvant systemic therapy.”

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Three-Drug Regimen Active in BRAF-Mutant Melanoma

Excerpt:

“Triplet therapy for advanced, BRAF V600-mutant melanoma led to objective responses in 73% of a small group of patients enrolled in a phase I trial, according to updated results reported at the 2017 ESMO Annual Congress in Madrid.

“Ongoing follow-up in the trial showed that 11 of 15 patients responded to the combination of pembrolizumab (Keytruda), dabrafenib (Tafinlar), and trametinib (Mekinist). Seven of the 11 responding patients had not progressed after a median follow-up of 20 months. ‘Updated results of the phase I portion of the KEYNOTE-022 trial confirmed previously reported efficacy of this triplet combination,’ said Antoni Ribas, MD, PhD, a professor of medicine, surgery, and molecular and medical pharmacology at the University of California at Los Angeles. ‘The results demonstrated durability of responses. No late or unexpected toxicities occurred with longer follow-up. The randomized phase II portion of KEYNOTE-022 is ongoing.’ ”

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Radiation-Immunotherapy Combination Can Slow Tumor Growth for Some Patients With Metastatic Late-Stage Cancer

Excerpt:

“A new study involving patients with stage IV cancer finds that treatment with radiation therapy and immunotherapy can halt the growth of tumors by stimulating the body’s immune system to attack the cancer. In the phase II trial, patients with end-stage cancer that had spread to the lungs or liver demonstrated a favorable response to the combined treatment. Between 30 and 60 percent of the patients, depending on the treatment arm, found that their cancer stopped spreading. Findings will be presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO).”

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Long-Term Survival Rates More Than Double Previous Estimates for Locally Advanced Lung Cancer

Excerpt:

“Long-term results of a phase III clinical trial indicate that survival rates for patients receiving chemoradiation for unresectable, locally advanced non-small cell lung cancer (NSCLC) may be more than twice as high as previous estimates. At five years following treatment with a standard dose of 60 Gray (Gy) radiation delivered in 30 fractions, the overall survival rate was 32 percent, setting a new benchmark of survival for patients with inoperable stage III NSCLC. The trial, RTOG 0617, also confirms that a standard dose of radiation therapy is preferable to a higher dose and that cetuximab offers no additional survival benefit for these patients. Findings will be presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO) in San Diego.”

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Ipilimumab Shows Promise in Mutated NSCLC, but Toxicities May Limit Use

Excerpt:

“The addition of ipilimumab to targeted therapy for the treatment of EGFR- and ALK-mutated non-small cell lung cancer demonstrated improved survival despite dose-dependent toxicities, according to results from a phase 1b trial presented at the International Association for the Study of Lung Cancer Multidisciplinary Symposium in Thoracic Oncology.

“Ipilimumab (Yervoy, Bristol-Myers Squibb), a CTLA-4 inhibitor, has demonstrated long-term responses in patients with melanoma; however, the drug is associated with a high rate of grade 3 and grade 4 immune-related adverse events.”

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Pivotal Role Remains With Bone-Targeting Agents in mCRPC

Excerpt:

“Prostate cancer researchers are continuing to explore strategies to optimally integrate bone-targeted agents into patient care.

“For example, an ongoing trial is assessing the combination of a radiopharmaceutical, radium-223 dichloride (Xofigo), with an androgen receptor-directed therapy, either abiraterone acetate (Zytiga) or enzalutamide (Xtandi). The open-label, phase IIa study is accruing patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint of the trial, which hopes to enroll 68 patients, is patient bone scan response rate (NCT02034552).”

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