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ESMO 2019

GSK

ZEJULA (niraparib)

GSK presented the data of Zejula, a PARP inhibitor, which improves PFS in women with first-line platinum responsive advanced ovarian cancer.

About PRIMA trial

PRIMA trial is Phase 3, double-blind, placebo-controlled study. The drug is indicated in patients with first-line ovarian cancer following platinum-based chemotherapy. The trial was conducted in BRCA mutation tumors, HR-deficient BRCA wild type tumors, HR-proficient tumors.

Results presented were:

· Reduction in risk of disease progression by 38%

· In HR-deficient subgroup, after 24 months, 91% of women were alive compared to 85% of women administered with placebo

· Anaemia, thrombocytopenia, and neutropenia were the frequent adverse events reported

GSK3359609

GSK presented the data of GSK3359609 in combination with pembrolizumab in patients suffering from head and neck squamous cell carcinoma. GSK3359609 is an ICOS receptor agonist.

INDUCE-1

Patients on monotherapy were indicated with 1 mg/kg GSK3359609. Patients in combination were administered with 0.3mg/kg GSK3359609 and 200 mg pembrolizumab.

Results:

In the patients administered with combination therapy: the overall response rate was 24%. Median progression-free survival was 5.6 months. 6% response rate was observed in patients who were on monotherapy.

PFIZER

Bavencio (avelumab)

Pfizer presented the data of Bavencio plus axitinib in patients with advanced renal cell carcinoma (RCC). The abstract also showed the data of Bavencio as monotherapy and in combinations against different cancers.

About JAVELIN trial

The trial demonstrated efficacy in renal cell carcinoma (RCC), metastatic Merkel cell carcinoma (mMCC) and some other solid tumors. The trial is a randomized, multicenter, open-label study.

Results of the study were:

Patients with Advanced RCC who did not undergo Upfront Cytoreductive Nephrectomy: Bavencio + axitinib showed shrinkage in 34.5% of patients versus 9.7%, in patients who were administered with sunitinib.

Patients with Advanced RCC with Sarcomatoid Histology: Bavencio + axitinib showed PFS of 7.0 months vs. 4.0 months in patients who were administered with sunitinib.

JANSSEN

ERLEADA (apalutamide)

Janssen presented the data of Erleada in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The drug is indicated in combination with androgen deprivation therapy.

About SPARTAN study:

SPARTaN is a Phase 3 study following a second interim analysis. The results show 25% reduction in death in patients treated with Erleada + androgen deprivation therapy compared to placebo + ADT.

Results

After 41 months, four-year OS rates were 71.1% in patients treated with Erleada compared to 64.7% in patients who were on placebo.

AMGEN

AMG 510

Amgen presented the data of AMG-510 with colorectal cancer and appendiceal cancer, and non-small cell lung cancer (NSCLC).

About Phase 1 study

The study enrolled 76 patients with KRAS G12C-mutant solid tumors. 92% of patients showed a controlled rate of cancer in patients suffering from CRC. In patients suffering from NSCLC, 54% of patients achieved a partial response and 46% achieved stable disease.

Results

In the trial, the patients were tested with four dose cohorts: 180 mg, 360 mg, 720 mg, and 960 mg

There were no major adverse events reported.

MERCK

Lynparza (olaparib)

AstraZeneca and Merck have presented the data of Lynparza. The drug is tested in combination with bevacizumab for newly-diagnosed advanced ovarian cancer.

PAOLA-1 trial:

Phase 3 trial intended to test Lynparza + bevacizumab combination therapy vs bevacizumab.

Results:

Progression-free survival was 22.1 months vs 16.6 months in patients with bevacizumab alone (PFS is measured in the median in months).

The safety was consistent with the established adverse events.

BMS

OPDIVO (nivolumab)

BMS presented the three Phase 3 CheckMates studies of Opdivo in patients suffering with melanoma and NSCLC.

  • CheckMate-238 study was conducted to determine three-year results in patients with Resected High-Risk Melanoma. Opdivo is being administered as an adjuvant treatment to Yervoy. Endpoint is the determination of RFS compared to Yervoy

  • CheckMate-067 study demonstrated long-term survival benefits (after 5 years) in patients suffering from advanced melanoma

  • CheckMate-227 to evaluate superior overall survival for Opdivo (nivolumab) + low dose Yervoy (ipilimumab) vs. chemotherapy in patients suffering from PDL-1 NSCLC

Results:

  • CheckMate-238: RFS rates of 58% and 45%, respectively

  • CheckMate-067: After 5 years, overall survival was 52% in patients administered with the Opdivo + Yervoy combination, 44% in patients on the Opdivo monotherapy and 26% in patients on Yervoy alone

  • CheckMate-227: Two-year survival rate was 40%in patients whose tumors expressed PD-L1

ROCHE

TECENTRIQ (atezolizumab)

Roche presented two studies of Tecentriq, one Phase 1b study in patients suffering from unresectable hepatocellular carcinoma and one in patients with advanced non-small cell lung cancer.

About studies:

Phase 1b in patients with unresectable hepatocellular carcinoma:

Non-randomised Tecentriq and Avastin cohort had confirmed objective response rate of 36%. Median progression free survival was 7.3 months. Safety profile was consistent with known safety profile.

IMpower 110 study in patients with NSCLC:

A Phase 3 study, compared Tecentriq (atezolizumab) as monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine. Overall survival was improved by 7.1 months compared to chemotherapy. Safety profile was consistent with known safety profile.

ALECENSA (alecitinib)

Roche has presented the data of Alecensa in first line in patients suffering from ALK-positive non-small cell lung cancer.

ALEX data:

Phase 3 studies, studied to prove the efficacy and safety of Alecensa versus crizotinib. Disease worsening was reduced by 57%. Progression-free survival was 34.8 months versus 10.9 months in patients who were on crizotinib.

ASTRAZENECA

TAGRISSO (osimertinib)

Tagrisso (osimertinib) was tested as first-line treatment in adult patients with EGFR-positive NSCLC.

FLAVRA trial:

Phase 3 trial, indicated in the first line for patients with EGFR-positive NSCLC. Median OS of 38.6 months was reported in patients administered with Tagrisso compared to 31.8 months in comparator arm (standard of care).

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