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'Oncology is back' at GlaxoSmithKline, says cancer R&D head

Anyone who thought GlaxoSmithKline plc exited the cancer space with its 2015 asset swap could not be more wrong, according to Axel Hoos, senior vice president of oncology research and development at the company.

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Axel Hoos, head of oncology R&D at GSK.

Source: GSK

Yet when the U.K. company traded its oncology portfolio for Novartis AG's vaccine business, many in the pharma community mistook the deal, Hoos said in an interview on the sidelines of the American Society of Hematology conference in Atlanta.

"I can now say, after 2.5 years of flying below radar, that our portfolio has matured to the point that we're back," Hoos said. "Oncology is back at GSK ... and we're not duplicating anything anyone else is doing."

Five years ago, the company decided to project what the next-generation of immunotherapies would be rather than piling on current therapy tracks, according to Hoos, who has considerable experience in the area after leading the immune system-boosting Yervoy to market during his time with Bristol-Myers Squibb Co.

"When we started building the immuno-oncology portfolio, we decided that we would not try to ride the wave that everybody else is riding because there's too much duplication and not enough value around," Hoos said.

"In I-O when you do, let's say, PD-1 blocking antibodies — there's 20 PD-1s in the clinic right now, some already on the market," Hoos said, referring to the checkpoint inhibitors that include Bristol-Myers' Opdivo and Merck & Co. Inc.'s Keytruda, as well as similar inhibitors from Roche Holding AG, AstraZeneca PLC, Merck KGaA and Pfizer Inc.

First up in this next-generation plan is GSK2857916, a monoclonal antibody that specifically targets BCMA, a biomarker prominent in the plasma cancer multiple myeloma. In a recent study, 60% of patients — many of whom had failed at least five prior therapies — responded to the treatment.

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Used in combination with chemotherapy, GSK2857916 reduced myeloma protein levels by more than 90% in over half the trial participants. Patients lived without the disease worsening — known as progression-free survival — for a median of nearly eight months.

GSK2857916 has already been awarded a breakthrough designation from the U.S. Food and Drug Administration, which helps speed up the approval process. Hoos said the company aims to launch the drug as a monotherapy in 2020 but is already exploring combination options, both with currently approved therapies and immunotherapy options in GSK's pipeline.

The rest of the oncology pipeline is still in relatively early days, but GSK's BCMA antibody is joined in the breakthrough designation category by GSK3377794, a T-cell receptor therapy that the company recently brought back in-house.

As these products move through the pipeline, GSK is on the hunt for more early-stage assets, according to comments from Luke Miels, its new head of pharmaceuticals, to Reuters.

CAR-T rival on the horizon

While these are novel therapies, they are still entering competitive markets. The BCMA antibody GSK2857916's study was led by researchers at the University of Pennsylvania, which also ran a recent trial for Novartis' chimeric antigen receptor T-cell, or CAR-T cell, therapy also targeting BCMA in multiple myeloma.

CAR-T therapy has stoked excitement with solid remission rates in other blood cancers, yet its complex, patient-unique process makes it difficult to scale up quickly. This, Hoos says, is a key advantage for other therapies in the same disease area.

"My expectation is that the CAR-Ts will take some time until they are scaled and can supply the multiple myeloma market, which is up to 30,000 patients a year in the U.S. alone," Hoos said.

The two approved CAR-T cell therapy makers, Novartis and Gilead Sciences Inc., are each aiming for about two dozen centers in the U.S. and have made quick turnaround time on the cell engineering a priority.

Even with the infrastructure in place, the therapies might not have a broad reach for different patients, Hoos argued. While all multiple myeloma will express the BCMA biomarker, researchers in the BCMA/CAR-T study did not include patients with a lower than 50% BCMA expression, according to Hoos.

"It's in a very selective patient population with a modality that is not accessible to everybody," he said. "Having an antibody that will be given to every patient with multiple myeloma, that is easy to manufacture, is a pretty much standard approach in the industry. It is something that we believe will be widely acceptable to patients."

GSK's multiple myeloma trial did produce vision problems in a number of patients, which researchers said was caused by the chemotherapy rather than the experimental antibody.