The Lynx Group

Expert Insights on Innovation in the Oncology Pipeline

December 2020, Vol 11, No 6

Total growth in the oncology pipeline in 2020 has been driven by targeted therapies, said Doug Long, Vice President, Industry Relations, IQVIA, at the 10th Annual Summit of the Association for Value-Based Cancer Care (AVBCC) in 2020.

At a year in which unit growth in oncology sales slowed because of the COVID-19 pandemic, with year-over-year overall growth in sales dropping from 16% to 8%, targeted therapies has been the only therapeutic category that has increased in overall dollar value, climbing 9% year-to-date, compared with a decline of 5.7% for cytotoxic agents, 0.5% for hormonal therapies, and 28.4% for radiopharmaceuticals.

The top 10 oncology drugs in the United States are all targeted therapies, Mr Long said; of these, the top 3 drugs are pembrolizumab (Keytruda), with a 5-year absolute sales growth of $7.6 billion; nivolumab (Opdivo), with a $3.6 billion growth; and palbociclib (Ibrance), with a $3.4 billion growth.

Despite the pandemic, the number of new drugs approved in 2020 by the FDA was higher than in the previous year (52 vs 48, respectively), with 40% of the new drugs being oncologic therapies. “The launches that needed to be delayed,” Mr Long said, “were those requiring a lot of physician visits, such as titration or multiple injections. Those were at a disadvantage, and some have not launched yet.”

New Launches in Oncology

New oncology agents that launched in 2020 include rituximab-pvvr (Ruxience), indicated for non-Hodgkin lymphoma and chronic lymphocytic leukemia; sacituzumab govitecan-hziy (Trodelvy), indicated for breast cancer; bevacizumab-bvzr (Zirabev), indicated for metastatic colorectal cancer and non–small-cell lung cancer; trastuzumab-qyyp (Trazimera), indicated for breast cancer and gastric or gastroesophageal junction adenocarcinoma; and isatuximab-irfc (Sarclisa), indicated for multiple myeloma.

Although immuno-oncology drugs currently represent a minority of the overall branded cancer therapies on the market, these agents are projected to grow strongly, with a cumulative annual growth rate of 29% anticipated through 2024 and a projected total sales for 2024 of $37 billion in the United States alone.

“The vast majority of the growth in oncology is being driven by immuno-oncology,” said Jeffrey Bockman, PhD, Executive Vice President, Cello Health BioConsulting (formerly Defined Health). “Between 2013 and 2024, the cumulative annual growth rate for immuno-oncology is [expected to be] 24%, compared with a 14% CAGR [compound annual growth rate] for overall oncology, and 11% for non–immuno-oncology agents,” he explained.

Immuno-Oncology

With 4720 agents in the current immuno-oncology global clinical pipeline, innovation is critical, Dr Bockman said.

“Although only about one-third of clinical stage assets in oncology are centered on immuno-oncology, that activity represents a disproportionate investment in start-ups, seed-funding series, and deal-making,” Dr Bockman noted. “There has been a lot of investment in targeting and manipulating T-cells. And there has been a doubling over the past 3 years of agents in the cell therapy space, not just CAR [chimeric antigen receptor] T-cell.”

Cell therapies have been front and center in the discussion around value and pricing, given the initial launches of the innovator drugs tisgenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta).

“There is now an effort to move these from the narrower settings of acute lymphocytic leukemia and large B-cell lymphoma into the biggest oncology market, which is of course solid tumors,” Dr Bockman emphasized. “A lot of engineering is needed to make that feasible, including the attempt to make these therapies truly off-the-shelf, which may allow for the ability to take out a lot of the logistics and costs that are an impediment to broader growth in this category.”

Significant current investment activity in new cancer therapies is currently aimed at achieving broader activity from checkpoint inhibitors, and using these agents in combination, to enable them to work better in larger populations of patients.

Dr Bockman pointed to the “checkpoint eligibility and response gap,” with only 45% of patients with cancer being eligible to receive a PD-L1 inhibitor, and less than 15% of those who are eligible for this therapy achieve a partial response or a complete response.

“Novel mechanisms of action and combinations are needed to provide more responders, with better response.”

Cost Issues

The novel therapies in oncology, including targeted therapies and immuno-onoclogy therapies, are presenting payers, policymakers, and patients with major challenges in terms of cost, suggested William Roth, Founding Partner, Blue Fin Group.

“Over the past 10 years, there has been a massive increase in out-of-pocket expenditures for patients. In just the last 7 years, that out-of-pocket spending has increased by 60%,” MR Roth observed. “Innovation is wonderful—we are saving lives and elongating lives, doing what we set out to do as healthcare providers—but the patient is experiencing a whole new level of shock to the pocketbook,” he added.

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