Abemaciclib/Pembrolizumab Combo Shows Early Promise for HR+/HER2- Breast Cancer

Excerpt:

“The combination of abemaciclib (Verzenio) and pembrolizumab (Keytruda) showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer, according to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium (SABCS).

“At a 16-week analysis, the objective response rate (ORR) with the combination was 14.3%, which was less than the response rate seen with single-agent abemaciclib in the MONARCH-1 trial (19.7%). However, the trial investigators noted that the median time to response for abemaciclib has historically been 3.7 months, suggesting the efficacy is likely to improve with longer follow-up. At 16 weeks, the ORR in the MONARCH-1 trial was 6.8%.”

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Continued Activity Reported for Pembrolizumab/Eribulin in TNBC

Excerpt:

“Updated results of the phase Ib/II ENHANCE1/KEYNOTE-150 study presented at the 2017 San Antonio Breast Cancer Symposium found that the combination of pembrolizumab (Keytruda) and eribulin (Halaven) was associated with a 26.4% objective response rate (ORR) for patients with metastatic triple-negative breast cancer (TNBC).

“In the open-label study, the ORR with the combination for untreated patients with metastatic TNBC (n = 65) was 29.2% (95% CI, 18.6%-41.8%). In a cohort of patients pretreated with 1 to 2 therapies (n = 41), the ORR was 22.0% (95% CI, 10.6%-37.6%). Across all treatment arms, there were 3 complete responses to the combination (2.8%).”

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Immunotherapy Shows Early Promise for Patients With Trastuzumab-Resistant Breast Cancer

Excerpt:

“A combination of pembrolizumab (Keytruda) and trastuzumab, tested in patients with trastuzumab-resistant advanced HER2-positive breast cancer, was well tolerated and had clinical benefit in patients whose tumors were positive for a biomarker for pembrolizumab, according to data presented from the phase Ib/II PANACEA trial at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.

“ ‘We wanted to investigate if immunotherapy approaches can work in patients with advanced HER2-positive breast cancer that is resistant to trastuzumab,’ said Sherene Loi, MD, PhD, associate professor at Peter MacCallum Cancer Centre in Melbourne, Australia, working with the International Breast Cancer Study Group (IBCSG).”

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Expert Highlights Immunotherapy Progress in Squamous Cell Lung Cancer

Excerpt:

“Combination regimens—particularly with checkpoint inhibitors and chemotherapy—are showing promise for the treatment of patients with squamous non–small cell lung cancer (NSCLC).

“Beyond the May 2017 FDA approval of pembrolizumab (Keytruda) plus carboplatin/pemetrexed for nonsquamous patients regardless of PD-L1 status, researchers are turning their focus to immunotherapy combinations in squamous patients in ongoing clinical trials. For example, the randomized, open-label, phase III IMpower131 study is evaluating the safety and efficacy of atezolizumab (Tecentriq) in combination with carboplatin/paclitaxel or carboplatin/nab-paclitaxel (Abraxane) versus carboplatin/nab-paclitaxel in chemotherapy-naïve patients with stage IV squamous NSCLC (NCT02367794). The trial, which has a primary endpoint of progression-free survival, is expected to enroll 1021 patients.”

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IL-12 Therapy Elicits Encouraging Response Rates in Melanoma

Excerpt:

“Immunopulse IL-12 monotherapy and in combination with pembrolizumab was associated with encouraging response rates and safety data in patients with melanoma who may not respond to anti-PD-1 therapy, according to a press release.

“The findings were presented at the 9th World Congress of Melanoma — A Joint Meeting with the Society for Melanoma Research. The data include a phase 2 Immunopulse IL-12 (OncoSec) monotherapy study with 51 patients and a phase 2 study of the immunotherapy in combination with pembrolizumab, which included 22 patients.”

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Immune-Stimulator Boosts Pembrolizumab in Melanoma Patients With “Cold” Tumors

Excerpt:

“Adding the immune stimulator ImmunoPulse IL-12 to pembrolizumab (Keytruda) produced promising activity among patients with melanoma identified as unlikely responders to anti–PD-1 therapies.

“Data from the phase II OMS-I102 trial presented at the 2017 World Congress of Melanoma showed that the combination induced an overall response rate (ORR) of 50% (n = 11) among 22 patients with baseline biomarker data suggesting they would not respond to anti–PD-1 therapy.”

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Merck’s KEYTRUDA® (pembrolizumab) More Than Doubled Median Overall Survival Compared to Chemotherapy After Two Years of Follow Up in First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with High Levels of PD-L1

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of updated overall survival (OS) findings, a secondary endpoint, from the phase 3 KEYNOTE-024 trial evaluating KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, as a first-line monotherapy in patients with non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (tumor proportion score [TPS] of 50 percent or more). The study included patients with squamous and nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations. Findings – which are based on more than two years of follow-up – will be presented in an oral presentation at the 18th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan (Abstract OA 17.06).”

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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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PD-1/IDO Combination Active in Advanced Melanoma

Excerpt:

“A majority of patients with advanced melanoma responded to the combination of pembrolizumab (Keytruda) and the investigational IDO1 inhibitor epacadostat, as reported at the European Society of Medical Oncology congress in Madrid.

“In phase I/II results from the ECHO-202/KEYNOTE-037 trial, the combination induced objective responses in 29 of 53 (55%) efficacy-evaluable untreated patients, including seven complete responses. Twenty-two of 38 evaluable patients (58%) responded to the recommended phase II dose of epacadostat (100 mg).”

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