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Clovis Announces Preliminary Q4 Financials; Provides Updates on Rubraca, Radionuclide Programs

NEW YORK – Clovis Oncology CEO Patrick Mahaffy outlined at the annual JP Morgan Healthcare Conference on Wednesday how the company is planning to achieve long-term financial stability by growing the market for its PARP inhibitor rucaparib (Rubraca) and by becoming a leader in targeted radionuclide therapy.

Rucaparib is currently Clovis' only marketed product. Earlier this week, the company said it is expecting Q4 revenues from rucaparib's global sales to be between $35.5 million and $36.1 million compared to $43.3 million in Q4 2020. For the full year, the company is expecting rucaparib sales of between $148.3 million and $148.9 million compared to $164.5 million in 2020.

Rucaparib is currently approved in the US as a maintenance treatment for platinum-responsive recurrent ovarian cancer patients regardless of their biomarker status. The drug is also approved as a third-line treatment for BRCA1/2-mutated ovarian cancer and for BRCA1/2-mutated, metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor treatment or taxane-based chemo.

"COVID has had an impact on the diagnoses and treatment patterns for ovarian cancer," Mahaffy said, estimating that the diagnosis of ovarian cancer is down around 25 percent compared to before the pandemic.

The company reported approximately $143.4 million in cash and cash equivalents as of Dec. 31. Clovis also has $27.8 million available in funding under a financing program inked in 2019 for up to $175 million with affiliates of TPG Sixth Street Partners to pay for the ongoing ATHENA clinical trial of rucaparib, which will readout this year.

Mahaffy said the company has committed to cutting costs and growing revenues in coming years to achieve financial stability for the company.

One way the company is hoping to grow revenues is by demonstrating the broad utility of rucaparib in earlier treatment lines and in combination with other drugs, in some cases in an all-comer population, unfettered by biomarker testing. Toward that end, Clovis is anticipating several study readouts. In Q1, the company will report top-line data from the first portion of the Phase III ATHENA trial comparing rucaparib against placebo in the first-line ovarian cancer maintenance setting.

"The population is ultimately an intent-to-treat all-comers population," Mahaffy said, explaining that the company will first look at outcomes in the population of patients with homologous recombination repair deficiencies, "who are likely to gain a significant benefit from a PARP inhibitor, but then, we step down to all comers."

However, according to Mahaffy, the highest risk readout for the company will come later this year from the second portion of the ATHENA trial, in which the drugmaker is exploring rucaparib with the checkpoint inhibitor nivolumab (Bristol Myers Squibb's Opdivo) against rucaparib monotherapy in the first-line ovarian cancer maintenance setting. Mahaffy said that this may be the first readout of a trial exploring the combination of an immune-oncology drug and a PARP inhibitor in this early treatment setting.

Data from studies in later stages of treatment with a PARP inhibitor and a PD-1/PD-L1 inhibitor have yielded mixed results. "There doesn't seem to be much in the way of synergy," Mahaffy said. "But in an earlier-line BRCA-mutated population, it looked as if the response was similar to monotherapy and the duration of response was about two times longer."

It's hard to parse these data from small trials, but "we're going to know a lot sometime in the second half of the year," when this portion of the ATHENA trial is slated to readout.

In Q2, data from the TRITON3 trial will determine whether the company can move rucaparib to the second-line mCRPC setting. The Phase III trial is comparing rucaparib against physicians' choice of chemo or second-line androgen deprivation treatment in mCRPC patients. The company will enroll patients with BRCA1/2 or ATM mutations.

If successful, Mahaffy said this will be the only PARP inhibitor that "outcompeted" docetaxel, which is the standard of care, and will allow the company to launch its drug in an earlier prostate cancer indication.

Clovis is also collaborating with 3B Pharma on developing targeted radionuclides. Within that partnership, Clovis last year began studying a FAP-targeting imaging agent and the radionuclide therapy FAP-2286 in the Phase I/II LuMIERE trial.

The company is settling the Phase II dose of FAP-2286 now, and after that will explore the therapy across six or seven solid tumor types. Mahaffy expects to present the first data from this trial at a medical meeting over the summer.

FAP is expressed in cancer-associated fibroblasts that occur in the tumor microenvironment but show up infrequently on normal tissues, making it a good target for an imaging agent and a therapeutic. FAP-2286 labeled with gallium-68 will be the imaging agent that identifies patients with FAP-positive tumors for the LuMIERE trial. Subsequently, patients with FAP-positive tumors will receive the therapeutic agent labeled with lutetium-177. "We are developing a kit to make the local manufacture of the gallium-labeled imaging quite a bit easier for the clinics," Mahaffy said.

Additionally, once a monotherapy dose is established in the LuMIERE study, the company this year will also begin exploring FAP-2286 in combination with an anti-PD-1 drug.

Clovis and 3B also have a discovery program, within which Clovis has identified another promising radionuclide agent. The firm hopes to submit an investigational new drug application for this agent with the US Food and Drug Administration in the second half of 2022.

"We are completely committed to the field of radionuclides and determined to emerge as a leader in this field," Mahaffy said, pointing out that Clovis is the only company with an FAP-targeted agent under clinical development.

The company has learned some hard lessons from being third to market in the PARP inhibitor space, where rucaparib competes with AstraZeneca's olaparib (Lynparza) and GlaxoSmithKline's niraparib (Zejula). "We're going to do our damnedest to be number one for the foreseeable future" in the FAP-targeted radionuclide space, Mahaffy said.