This weekend on the ground at the ESMO Congress 2019, 27 September – 01 October, Barcelona, organized in partnership with the European Association for Cancer Research (EACR), several of our faculty including VHIO’s Director Josep Tabernero and Maria Alsina, Medical Oncologist and Clinical Investigator of our Gastrointestinal & Endocrine Tumors Group led by Teresa Macarulla, have been contributing to the many must-have conversations focused on the field of immunotherapy against cancer.

One such study* to showcase earlier today as a late breaking abstract during Proffered Paper 2 – Gastrointestinal tumours, non-colorectal, senior authored by Josep, who also serves as ESMO and ESMO Congress President, revealed results on the effectiveness of pembrolizumab, a monoclonal antibody which has previously been shown to be effective against multiple tumor types. Presented by Kohei Shitara, National Cancer Center Hospital (Kashiwa, Japan), findings reported the efficacy of this novel agent as first line treatment for patients with advanced gastroesophageal junction adenocarcinoma.

Co-led by Josep, this present KEYNOTE-062 used data from the phase III randomised Keynote-062 trial, an international multicenter study in which VHIO also participated, to verify the activity of pembrolizumab as monotherapy or in combination with chemotherapy versus chemotherapy alone as first line therapy. More than 750 patients were enrolled allocated to three groups. One arm received chemotherapy alone, another received pembrolizumab, and the third, combined treatment. The median follow-up was more than eleven months.

The initial results of the study were presented earlier this year at ESMO’s 21st World Congress on Gastrointestinal Cancer, also held in Barcelona from 03 – 06 July this year. “We showed that treating gastric and gastroesophageal junction tumors with pembrolizumab alone, either substituting conventional chemotherapy or as a combination of the two, were not inferior. Our results were more favorable in patients with high PDL1 expression,” noted Josep, who also directs our Gastrointestinal and Endocrine Tumors Group.

Specifically focused on a patient population with microsatellite instability, representing between 8-10% of all gastrointestinal tumors, results reported today showed a spectacular benefit of first line immunotherapy versus chemotherapy. “Although our subset patient population is small, clinical benefit was substantially enhanced. Patients treated with pembrolizumab presented a survival hazard ratio (HR) of 0.3, showing a clear benefit in this group of patients treated with immunotherapy,” he explained.

This present study also showed the safety profile of the monoclonal antibody as more favorable than that of chemotherapy, with fewer side effects. These findings point to potentially treating this patient population with pembrolizumab alone as first line therapy.

Also based on the results of the KEYNOTE-062 trial, María Alsina, presented results on the measured impact of first line treatment with pembrolizumab versus chemotherapy on patients’ quality of life. Selected as a late breaker during a Poster Discussion Session – Gastrointestinal tumors, non-colorectal, this study analyzed the quality of life data of patients enrolled.

Specifically, all patients who received one or more doses of the study treatment completed one or more health-related quality of life assessments. This analysis was based on two quality of life questionnaires adapted for oncological and stomach cancer patients (QLQ-C30 and QLQ-STO22, respectively). The data of almost 500 patients were assessed. “Our results show that quality of life was similar in both groups, irrespective of the treatment received. Indeed, treatment with pembrolizumab showed better control of nausea and vomiting, according to the QLQ-C30 survey”, explained Maria.

“These findings, together with the efficacy data of Keynote-062, support a risk to benefit ratio favorable to immunotherapy as first line therapy in patients with stomach and/or gastroesophageal junction cancer,” she concluded.

Presented by Ana Oaknin, Principal Investigator of our Gynecological Malignancies Group during this morning’s Proffered Paper Session on Gynecological Cancers, interim results from a combination cohort study of the phase I/II investigational immune-therapy trial to assess the safety and effectiveness of nivolumab, and nivolumab in combination against virus-associated tumors -Checkmate 358***- were revealed. 

To access this VHIO news please click here.

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*Pembrolizumab with or without chemotherapy vs chemotherapy in patients with advanced G/GEJ cancer (GC) including outcomes according to Microsatellite Instability-High (MSI-H) status in KEYNOTE-062.

 

**Health-related quality of life (HRQoL) impact of pembrolizumab (P) versus chemotherapy (C) as first-line (1L) treatment in PD-L1–positive advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

 

*** Efficacy and safety of nivolumab (Nivo) + ipilimumab (Ipi) in patients (pts) with recurrent/metastatic (R/M) cervical cancer: Results from CheckMate 358.

 

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*Pembrolizumab with or without chemotherapy vs chemotherapy in patients with advanced G/GEJ cancer (GC) including outcomes according to Microsatellite Instability-High (MSI-H) status in KEYNOTE-062.

**Health-related quality of life (HRQoL) impact of pembrolizumab (P) versus chemotherapy (C) as first-line (1L) treatment in PD-L1–positive advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

*** Efficacy and safety of nivolumab (Nivo) + ipilimumab (Ipi) in patients (pts) with recurrent/metastatic (R/M) cervical cancer: Results from CheckMate 358.