Weekend Highlights from 2019 ASCO Annual Meeting

There was a flurry of activity during the first few days of the American Society of Clinical Oncology, with multiple presentations made showing the benefits of various oncology treatments. BioSpace has put together a roundup of some of these presentations.

Roche – In December, Swiss pharma giant Roche won approval for a combination of Tecentriq and Avastin for treatment of some metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The combination was approved as a first-line treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. On Saturday, Roche announced results from a pre-specified exploratory analysis from the Phase III IMpower150 study, which was used as a basis for the regulatory approval. Results showed that the combination of Tecentriq, Avastin and chemotherapy gave patients with chemotherapy-naïve, metastatic non-squamous non-small cell lung cancer (NSCLC), with baseline liver metastases an overall survival (OS) advantage compared with the combination of Avastin and chemotherapy alone. Median OS was 13.3 months vs. 9.4 months, the data showed. “Initial treatment with Tecentriq, Avastin and chemotherapy may represent an important new option for people with baseline liver metastases, as their risk of death was reduced by nearly half and 60% responded to the combination treatment,” Sandra Horning, Roche’s chief medical officer and head of Global Product Development, said in a statement.

AstraZeneca -- Olivier Nataf, head of AstraZeneca’s U.S. oncology business unit, touted results from the Phase III PACIFIC trial for Imfinzi (durvalumab) in unresectable, Stage III non-small cell lung cancer (NSCLC) over the weekend. He summed up the results in a short statement, “sustainable, overall survival.” A presentation of a post-hoc analysis of the trial showed longer OS evidence in patients with this particular kind of cancer, the only immunotherapy to demonstrate this kind of survivability for this cancer, the company said. The OS rate was 57% at three years for patients receiving Imfinzi vs. 43.5% for placebo following concurrent chemoradiation therapy (CRT). Median OS was not yet reached with the Imfinzi arm versus 29.1 months for placebo. The post-hoc analysis provided an additional year of follow-up data that showed Imfinzi provided consistent efficacy, maintaining a 31% reduction in the risk of death vs. placebo after CRT.

AstraZeneca also presented additional data from its Phase III POLO trial. Data presented by AstraZeneca and Merck showed Lynparza, a PARP inhibitor, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as first-line maintenance therapy alone in patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas in patients who haven’t responded to platinum-based chemotherapy. Lynparza reduced the risk of disease progression by 47% compared to placebo. The median PFS for patients treated with Lynparza was 7.4 months, compared to 3.8 months for those on placebo. The companies said there were more than twice as many patients remaining progression free at both one year, 34% to 15% and two years, 22% vs. 10%, respectively.

Sanofi – Data from the Phase III ICARIA-MM trial demonstrated that isatuximab added to pomalidomide and dexamethasone showed statistically significant improvements compared to pomalidomide and dexamethasone alone in patients with relapsed/refractory multiple myeloma (RRMM). Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell. The isatuximab combination therapy showed a statistically significant improvement in progression-free survival of 95%. Also, Sanofi said the median progression-free survival was longer in the isatuximab combination therapy arm than pom-dex alone, 11.53 months vs. 6.47 months. Sanofi also reported that the isatuximab combination therapy demonstrated a significantly greater overall response rate, compared to pom-dex alone 60% vs. 35%.

Spectrum Pharmaceuticals – Nevada-based Spectrum announced integrated analysis results from two Phase III clinical trials of Rolontis, a long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing myelosuppressive cytotoxic chemotherapy. The analysis found that integrated efficacy and safety data from the two trials, ADVANCE and RECOVER, were consistent with results from the individual trials. The data demonstrated that Rolontis was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of treatment.

Novartis – In the Phase III MONALEESA-7 trial, Novartis Kisqali in combination with endocrine therapy extended the life of women with human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. The Swiss company said OS rates in the intent-to-treat population at 42 months were 70.2% for Kisqali combination therapy compared to 46% for endocrine therapy alone. At the time of data cut-off, 35% of women taking Kisqali combination therapy were continuing the treatment. Results from subgroup analyses showed that Kisqali plus an aromatase inhibitor demonstrated a 30% reduced risk of death compared to an aromatase inhibitor alone. Kisqali plus tamoxifen demonstrated a 20.9% reduced risk of death compared to tamoxifen alone, Novartis said.