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Immuno-oncology at ASCO: survival data, combinations and new indications

The abstracts reveal heaps of strong contenders in the NSCLC category

BMSThe countdown has begun to the annual American Society of Clinical Oncology (ASCO) congress to be held in Chicago next month, with developments in immuno-oncology once again taking centre stage.

The abstracts from the conference have now been published, and once again sparked a rash of share price rises and declines as investors and analysts sift through for studies that will have an impact on the fortunes of established and emerging cancer drugs and their developers.

Standout examples of that this year include Jounce Therapeutics - which fell dramatically after data from a phase I trial of its ICOS agonist antibody JTX-2011 alongside Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) were made public. Meanwhile, Loxo Oncology rocketed on the strength of early-stage data with its RET inhibitor LOXO-292, a targeted cancer drug.

For the big players in immuno-oncology like BMS and Merck & Co, the ASCO abstracts reveal a raft of studies aimed at showing improved survival as well as activity in combination regimens and new indications. And as was the case last year, the battleground is shaping up to be the big non-small cell lung cancer (NSCLC) category, particularly first-line treatment.

BMS' Opdivo has struggled to gain a foothold in the first-line setting, but will present the first analysis of its phase III CheckMate-227 trial in Chicago, which it hopes will help it compete with Merck & Co's Keytruda.

The trial pairs Opdivo with chemotherapy as well as Opdivo plus CTLA4 inhibitor Yervoy (ipilimumab) versus chemotherapy in first-line NSCLC patients with low levels of PD-L1 expression - a group for which Keytruda is already approved and increasingly used.

Other trials will look at the combination of Opdivo with Celldex’s anti-CD27 antibody varlilumab in ovarian cancer, as well as Nektar’s CD122-biased agonist NKTR-214 and anti-IL-8 monoclonal antibody BMS-98625 in advanced cancers. BMS will also present new data on Opdivo in Merkel cell carcinoma and triple-negative breast cancer (TNBC).

Merck - which has been in the ascendency after a string of approvals extending use of Keytruda - is stepping up the pressure at ASCO, with overall survival (OS) data from the KEYNOTE-042 trial of Keytruda monotherapy compared to chemotherapy in first-line NSCLC ‘all-comers’.

KeytrudaThe company has already revealed that the trial hit the mark on OS, making Keytruda a candidate for patients regardless of whether their cancer is squamous or non-squamous in origin and the level of PD-L1 expression.

Lynparza in prostate cancer

There will also be the first data for Keytruda in combination with AstraZeneca’s PARP inhibitor Lynparza (olaparib) in castration-resistant prostate cancer as well as studies in small-cell lung cancer, gastric or gastroesophageal junction (G/GEJ) cancer and Merkel cell carcinoma.

Meanwhile, companies following after BMS and Merck, such as Roche, AZ and Merck KGaA/Pfizer, are also trying to carve out territory for their new drugs, and will be showcasing their efforts at ASCO.

For Roche, the high points of the immuno oncology programme at ASCO will be updated results from trials of PD-L1 inhibitor Tecentriq (atezolizumab) in first-line NSCLC treatment, as it tries to remove Merck’s stranglehold on that sector.

On the agenda are overall survival data from the IMpower150 study of Tecentriq plus Avastin (bevacizumab) and chemotherapy (carboplatin and paclitaxel) in people with previously-untreated, non-squamous NSCLC, as well as new PFS data from the IMpower131 trial of Tecentriq and chemotherapy in first-line squamous NSCLC.

There will also be presentations on the Tecentriq/Avastin combination in advanced renal cell carcinoma (RCC) and first-line hepatocellular carcinoma (HCC), as well as data on Tecentriq’s impact on tumour mutational burden (TMB) cancers.

AZ won’t be ready to report the much-anticipated OS data from its MYSTIC trial of PD-L1 inhibitor Imfinzi (durvalumab) and CTLA4 inhibitor tremelimumab versus chemotherapy in first-line NSCLC, but will have new results to report in TNBC, mesothelioma and other solid tumours.

The Merck/Pfizer partners are highlighting long-term data for PD-L1 inhibitor Bavencio (avelumab) in Merkel cell carcinoma as well as results in NSCLC, bladder cancer and mesothelioma. Also on the agenda are preliminary clinical results with M7824, an investigational TGF‑beta trap/anti-PD-L1 bi-functional immunotherapy fusion protein in human papillomavirus (HPV)-associated cancers and second-line NSCLC.

Finally, PD-1 latecomers Sanofi and Regeneron will share the first results from an early-stage trial of their candidate cemiplimab in NSCLC at ASCO, as a monotherapy in patients who have relapsed after chemotherapy.

Article by
Phil Taylor

17th May 2018

From: Research

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