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5 questions ESMO cancer drug data might answer

Typically, the American Society of Clinical Oncology’s annual meeting is the definitive showcase of cancer research each year.

But recently, the field’s findings have spilled beyond the perennially Chicago-based conference, as surging investment into targeted treatments and immunotherapies are resulting in a steady steam of new data. Other meetings, such as those of the American Association of Cancer Research, the World Conference on Lung Cancer and the European Society of Medical Oncology, have been the beneficiaries.

ESMO’s annual congress takes place this month in Barcelona, Spain, stretching from Sept. 27 through Oct. 1. A review of the conference schedule suggests the meeting could deliver answers to a number of pressing questions, including the five below. Presentation times are listed at the end.

  1. Will AstraZeneca remain the king of PARPs?

    First-mover advantage and mostly positive clinical trials have helped keep AstraZeneca’s Lynparza ahead of the competition, with a sales run rate that could make it a blockbuster product this year.

    But fellow British pharma GlaxoSmithKline aims to compete in one of the bigger indications for the targeted treatment class, known as PARP inhibitors. At ESMO, data from GSK’s PRIMA study of Zejula will duel against results from Lynparza’s PAOLA-1 in successive presentations on Sept. 28.

    Both studies are of newly diagnosed patients treated with the respective drugs following response to chemotherapy. PAOLA, which was academic-run, added Lynparza to Roche’s Avastin and resulted in patients living longer without their disease progressing when compared to Avastin alone.

    PRIMA, by comparison, tested Zejula alone against placebo. The company reported results showing Zejula also resulted in patients living longer without their tumors growing again. No detailed data for either trial have been released, so this conference should be revealing.

    Not to be outdone, AbbVie is keen to get its experimental PARP inhibitor veliparib before oncologists, with data from the VELIA study in which veliparib and chemotherapy were combined to treat newly diagnosed ovarian cancer patients. Several clinical setbacks have dimmed expectations for veliparib, making this year’s ESMO a shot at redemption for AbbVie’s R&D team.

  2. Can Bristol-Myers Squibb persuade oncologists to use Opdivo-Yervoy in first-line lung cancer?

    That clearly will be the goal of Bristol-Myers’ presentation of final results from one part of its complicated CheckMate-227 study. But the advantage in immuno-oncology has now decidedly swung to Merck & Co.’s Keytruda plus chemotherapy in previously untreated non-small cell lung cancer.

    CheckMate-227 had two parts, one of which compared Opdivo plus Bristol-Myers’ other immunotherapy Yervoy to chemo, while the second pitted Opdivo and chemo against chemo alone. Had the second part succeeded, Opdivo might have had a chance at competing with Keytruda.

    Only the first part did, however, extending overall survival in patients whose tumors express a biomarker called PD-L1. The trouble with the Opdivo-Yervoy combination is the latter drug’s well-known side effect profile, which includes severe and sometimes fatal immune-mediated adverse reactions.

    Keytruda monotherapy is already cleared to treat PD-L1 expressors, making Opdivo together with Yervoy a tough sell.

    ESMO attendees will need to see something special in the CheckMate-227 data to change their treatment practices. A one-year survival rate of 69% or better, along with 75% reporting manageable toxicity, is a likely bar, wrote Cantor Fitzgerald analyst Louise Chen in a note to clients.

  3. Will Amgen’s KRAS data continue to excite?

    All it took were data from 10 lung cancer patients to turn AMG 510, an early-stage cancer drug developed by Amgen, into one of the company’s most valuable experimental assets.

    Presented in June, the preliminary results showed AMG 510 shrunk tumors spurred to growth by mutations in an oncogene known as KRAS. Blocking the aberrant signaling caused by those alterations has been the ‘white whale’ of cancer research for decades, said Sanket Agrawal, who heads Amgen’s team developing the drug, in an August interview.

    Since then, Amgen’s given a fuller picture of the drug, revealing in September data that showed its potential to become the first KRAS-targeting medicine as well as its very real limits.

    ESMO will give oncologists and Amgen investors a more detailed look at AMG 510 in another cancer type, colorectal rather than lung. The company estimates about 3% of colorectal tumors harbor the specific KRAS variant that AMG 510 targets, compared to about 13% of lung cancers.

    Colorectal tumors, however, seem to be less responsive to AMG 510, at least initially. In June, Amgen didn’t report any responses to treatment, although it’s since disclosed some patients have experienced reductions in tumor size.

    At ESMO, the drugmaker will present expanded data across all 76 patients in the Phase 1/2 study. R&D head David Reese has told investors to expect “relatively similar data” in lung compared to September’s disclosure, making how the drug performs in colorectal a focus.

    Michael Yee, an analyst at Jefferies, expects shares in Amgen could trade up or down by 2% to 4% depending on how the update is received.

  4. Can drugs from Novartis, Lilly unseat Ibrance?

    Pfizer’s Ibrance is one of the most successful cancer drugs on the market, earning $1.2 billion in sales over the three months from April to June.

    That’s despite the approval of two competing drugs from pharma rivals Novartis and Eli Lilly, which market Kisqali and Verzenio, respectively. All three drugs, called CDK 4/6 inhibitors, disrupt enzymes thought to help drive tumor growth.

    But Kisqali and Verzenio have yet to enjoy much commercial success. Detailed survival results set to be disclosed by Novartis and Lilly on Sept. 29 could provide a boost.

    Set to be announced in back-to-back sessions, the study data are from trials testing the drugs together with fulvestrant in postmenopausal women who have hormone positive, HER2 negative advanced breast cancer — a patient population ineligible for drugs like Roche’s Herceptin.

    Both companies have disclosed their respective treatments led to statistically significant improvements in survival, but detailed data are not available.

    The studies aren’t exactly identical — Novartis’ included previously untreated women as well as those who had received other first-line therapy — but results from each will go some ways to settling market position. (Novartis has also reported another trial, called MONALEESA-7, showed a survival benefit to Kisqali in younger, premenopausal women.)

  5. Can Roche clear the air on PD-(L)1s in bladder cancer?

    Detailed data from Roche’s IMvigor-140 study, which were toplined last month, should help oncologists determine which patients are best suited for frontline treatment with the Swiss pharma’s Tecentriq plus chemotherapy.

    Based on early data analysis from this study and a second trial of Keytruda, the Food and Drug Administration restricted the use of PD-(L)1 immunotherapies to patients in whom at least 5% of tumor cells express PD-L1. Study participants with lower expression had shorter survival times, the regulator said.

    At ESMO, Roche will have details on the magnitude of the Tecentriq-chemo combo’s benefit in reducing the risk of disease worsening or death compared to chemo alone. The pharma could possibly also have data on overall survival, the analysis of which was incomplete when Roche disclosed the headline results.

    Tecentriq has been a leader among PD-(L)1 therapies in urothelial cancer, in which it got its first approval, but Merck is coming up quickly with a similar first-line chemo-combo study of Keytruda called KEYNOTE-361.

Studies of note to be read out at ESMO’s annual meeting
Drug Study name Developer ESMO presentation
Zejula PRIMA GlaxoSmithKline 4:30 pm, Saturday, Sept. 28
Lynparza PAOLA-1 AstraZeneca, Merck & Co. 4:42 pm, Saturday, Sept. 28
AMG 510 N/A Amgen 4:52 pm, Saturday, Sept. 28
veliparib VELIA AbbVie 5:08 pm, Saturday, Sept. 28
Opdivo, Yervoy CheckMate-227 Bristol-Myers Squibb 5:32 pm, Saturday, Sept. 28
Verzenio MONARCH-2 Eli Lilly 4:30 pm, Sunday, Sept. 29
Kisqali MONALEESA-3 Novartis 4:45 pm, Sunday, Sept. 29
Tecentriq IMvigor-130 Roche 5:48 pm, Monday, Sept. 30

SOURCE: Companies, ESMO