Here’s What Happened at ESMO 2018 This Weekend: Novartis, Pfizer, and More

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The European Society of Medical Oncology was in full swing this weekend as multiple companies showed off mid- and late-stage assets that could change the way some patients are treated for their cancer. This morning, BioSpace takes a look at some of the announcements from the esteemed conference.

Novartis – Phase III results from Novartis’ SOLAR-1 trial showed BYL719 (alpelisib), an investigational alpha-specific PI3K inhibitor, in combination with the breast cancer drug fulvestrant, reduced the risk of death or progression in some breast cancer patients by 35 percent in comparison to patients treated with fulvestrant alone.

The Novartis combination nearly doubled the median progression-free survival in some breast cancer patients, the company said. The combination drug demonstrated a median progression-free survival of 11 months in patients with PIK3CA mutated hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. The patients treated in the trial had already experienced progression of their disease following treatment with an aromatase inhibitor with or without a CDK4/6 inhibitor, the company added. The PFS rate of 11 months was in comparison to 5.7 months in patients treated with fulvestrant alone. In addition to the PFS, Novartis said the overall response rate seen in patients on the combination treatment, which includes tumor reduction size of at least 30 percent, was more than double that of patients treated with fulvestrant alone. Patients treated with the combination saw an ORR of 36 percent compared to 16 percent of those receiving fulvestrant alone.

Novartis said it will continue to evaluate the data from SOLAR-1, but will begin discussions with regulatory agencies across the globe.

Pfizer – Late-stage data from Pfizer’s PALOMA-3 trial showed that a combination of Ibrance (palbociclib) and fulvestrant delivered an overall survival improvement of nearly seven months in comparison to patients treated with a placebo plus fulvestrant alone. However, Pfizer noted that those results from its combination trial did not reach the threshold of statistical significance, which had been set at a median overall survival of 34.9 months versus 28 months. It was clinically meaningful, though, Pfizer said. A combination of Ibrance, an oral inhibitor of CDKs 4 and 6, and fulvestrant are being examined as a potential treatment for women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease progressed on or after prior endocrine therapy. Overall survival is a secondary endpoint of PALOMA-3, and the trial design was not optimized to detect a statistically significant difference in OS, Pfizer noted.

The primary endpoint of the trial was median progression-free survival. In the updated PFS analysis, Pfizer said the combination if Ibrance and fulvestrant showed a statistically significant and clinically meaningful 6.6-month mPFS improvement compared to placebo plus fulvestrant. The combination medication offered 11.2 months of PFS versus the 4.6 months of PFS with placebo plus fulvestrant, the company said.

Roche – At ESMO, Roche announced data from the Phase III Impassion-130 study showed that Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer. Swiss pharma giant Roche said the combination of Tecentriq and Abraxane significantly reduced the risk of disease worsening or death (PFS) compared with chemotherapy alone in all randomized patients and the PD-L1-positive population. The combination treatment is being developed as a first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer. Roche said Tecentriq and nab-paclitaxel significantly reduced the risk of disease worsening or death in both the intention-to-treat and PD-L1-positive populations.

Roche noted that at the time the interim analysis was presented, OS had not been met in the intent-to-treat population, but showed a clinically meaningful 9.5-month OS improvement in the PD-L1-positive population.

In addition to the breast cancer news, Roche subsidiary Genentech announced positive results from its Phase III IMpower 130 study of Tecentriq plus chemotherapy as an initial treatment of people with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC). The analysis showed that the combination of Tecentriq plus chemotherapy helped people live significantly longer compared to chemotherapy alone, a median overall survival of 18.6 months versus 13.9 months. Genentech also noted that the combination therapy significantly reduced the risk of disease worsening or death in comparison to chemotherapy alone.

Servier and Taiho Oncology – Clinical data from the Phase III TAS-102 Gastric Studyevaluating Lonsurf  (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care, met its primary endpoints in patients with heavily pre-treated metastatic gastric cancer who have progressed or are intolerant to previous lines of therapy. The study’s primary endpoint was overall survival, with a secondary endpoint of PFS. In the study, patients treated with trifluridine/tipiracil showed a clinically meaningful and statistically significant improvement in OS compared with placebo and a 31 percent risk reduction of death. Servier said those results translate into a prolonged median survival difference of 2.1 months in comparison to placebo. The Lonsurf arm saw 5.7 months of OS versus 3.6 months for placebo.

Additionally, Servier said its combination treatment demonstrated a statistically significant improvement in PFS and time to deterioration of ECOG performance status versus placebo. Based on the results, Servier said it filed a new application for an additional indication for gastric cancer to the European Medicines Agency for Lonsurf.

Related: Check out BioSpace’s coverage of Bristol-Myers Squibb at ESMO here and coverage of AstraZeneca and Merck & Co. here.




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