ASCO 2019 Preview – in partnership with Kantar

ASCO’s 2019 conference is due to begin in just a few days’ time, highlighting the latest cutting edge cancer drugs and technology. As part of pharmaphorum’s coverage of the event, in partnership with Kantar, Richard Staines presents an overview of the most promising medicines that will be showcased at the conference in Chicago.

Friday

The conference begins as ever on the last Friday in May, and Johnson & Johnson will provide one of the highlights of the first day with data from its Erleada (apalutamide) prostate cancer drug.

The company’s Janssen unit already announced that it had unblinded the TITAN study in patients with metastatic castration-sensitive prostate cancer (mCSPC) in January, but this will be the first time that we get the chance to see detailed data.

An Independent Data Monitoring Committee made the recommendation after analysis showed progression-free survival and overall survival primary endpoints had been met, and this will be the first time that details from TITAN have been made public.

J&J’s own Zytiga has been approved in this earlier form of prostate cancer, but the company needs to find a more effective or safer successor to compete against cheaper generics that are already on the market.

AstraZeneca and Merck & Co have been developing its poly (ADP-ribose) polymerase (PARP) inhibitor Lynparza (olaparib) for metastatic castration resistant prostate cancer, a more advanced form of the disease and will unveil results of its TOPARP-B trial on the same day.  Early abstract release indicates that a strong response rate was observed in the overall population, driven heavily by activity in patients with a BRCA mutation.  While these results won’t be practice changing on their own, they provide evidence supporting the ongoing Phase 3 trials with Lynparza in HRD+ mCRPC.

Saturday

Novartis will kick off proceedings on Saturday with data from a phase 2 open-label study of its spartalizumab, a PD-1 drug that is being tested against advanced solid tumours and blood cancers – although the company is playing catch-up with the likes of Merck & Co who already have blockbuster drugs approved in this category. However, developing a PD-1 in-house will prevent Novartis relying on its rivals when developing combination therapies.

Bristol-Myers Squibb will outline how techniques such as gene expression profiling helped identify a new tumour-associated biomarker, and how its researchers used artificial intelligence (AI) to measure immune cells and their spatial location around tumours. This could help the company understand how immunotherapies interact with tumours and inform clinical development strategies in the future.

Merck & Co’s Keytruda is already a blockbuster thanks to its approval in a whole raft of cancers. The US biotech is trying to find ways to improve its effectiveness, in particular its response rate.

Saturday will see data from several trials that are testing it in combination with Eisai’s Lenvima (lenvatinib). The first data from the combination comes just after lunch when the companies will publish data from a phase 3 trial in endometrial cancer. Data from lung cancer will be revealed on Sunday, followed by liver cancer and melanoma on Monday.

Later in the day Gilead’s Kite unit is to unveil new data from ZUMA-3, a phase 1/2 study of a next generation CAR-T drug, KTE-X19, in adults with relapsed/refractory acute lymphoblastic leukaemia.

Sunday

Merck KGaA and GlaxoSmithKline are ambitiously testing their M7824 fusion protein immunotherapy that combines a PD-L1 inhibitor, with the extracellular part of human transforming growth factor (TGF-beta) receptor 2 protein.

This drug now has a generic name, bintrafusp alfa, and German Merck thinks this two-pronged mechanism has great potential.

It is taking the fight straight to its US namesake Merck & Co by testing it against Keytruda (pembrolizumab) in an open label study in first line non-small cell lung cancer (NSCLC), a highly lucrative indication that has decided the commercial success of all the marketed immunotherapies so far. Trial-in-progress information is available in a poster session on Sunday morning.

Merck & Co and AstraZeneca will present further data from Lynparza and the phase 3 POLO trial as a maintenance treatment in metastatic pancreatic cancer with germline BRCA mutation. We already know from a top-line data announcement earlier this year that the drug works in this indication in patients whose disease has not progressed on platinum-based chemotherapy.

The Plenary presentation on Sunday afternoon will flesh this out and give more detail for scientists keen to find treatments for this insidious cancer, and hope for patients who are looking for new therapies to extend and improve their lives.

Monday

Seattle Genetics will present details of EV-201, also known as enfortumab vedotin monotherapy in locally advanced metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors.  The company previously announced response rate data via press release, but this will be the first detailed look at this data which is expected to form the basis for U.S. regulatory filing in H2 2019.

Bayer will present additional data on its larotrectinib in TRK fusion cancers, a precision medicine that works on cancers of any origin in the body that are driven by the mutation driven by tropomyosin receptor kinase (TRK). An oral presentation on Monday afternoon will give further details of this approach as measured in a small sample of fusion cancer patients with evaluable brain metastases.

Tuesday

US biotech MacroGeneics has made waves with its margetuximab in patients with HER2-positive metastatic breast cancer.

It has already announced it had improved progression-free survival compared with standard of care in patients already treated with HER2 targeted therapies such as Roche’s Herceptin (trastuzumab) and chemotherapy.

The Maryland-based firm will present details of the phase 3 SOPHIA study on Tuesday morning – giving more depth to previously announced results showing a median PFS of 6.9 months, an improvement of 1.8 months compared with the standard care arm in the phase 3 trial.

There are no FDA-approved therapies after progression on Herceptin, Perjeta, and Kadcyla, and results suggest this could be a new treatment option.

pharmaphorum will be providing live coverage of ASCO in partnership with Kantar – look out for our live blog, and other social media coverage throughout the duration of the event. CLICK HERE to view the exclusive live coverage.