Biotech, in brief

Roche's pill divarasib beat the two lung-cancer pills already on sale for the same faulty gene, in a final-stage trial shown on Sunday. [1][2]

The results were shown in Madrid at ESMO, the yearly meeting of the European Society for Medical Oncology, a society of cancer doctors. [2]

The cancers carry KRAS G12C, a gene change that jams a growth switch in the 'on' position. About one in eight people with the most common lung cancer have it. [1]

The trial gave 338 people whose cancer had grown after earlier treatment either divarasib or an older pill: Amgen's Lumakras or Bristol Myers Squibb's Krazati. [2]

Half the patients on divarasib were still alive at 17.7 months, against 12 months on the older pills. Their risk of death was 44% lower. [1][2]

Tumours shrank in 58% of patients on divarasib and 32% on the older pills. At one year, 44% against 24% were alive with no tumour growth. [1]

Fewer patients stopped divarasib because of side effects, 4.8% against 11.7%, even though they stayed on it more than twice as long. [1]

Roche said in July that the trial had met its goals, but held back the numbers until this meeting. [2]

Drugmakers rarely test against a rival's drug, Roche's deputy medical chief Stefan Frings told Fierce Biotech, but a head-to-head win helps convince payers, doctors and patients. [2]

Roche dropped a trial against docetaxel, an older chemotherapy, to run this one against the two pills instead. [2]

The older pills sell little: Krazati brought in $55 million and Lumakras $111 million in the second quarter. Roche hopes divarasib will reach 1 to 2 billion Swiss francs a year at its peak. [2]

Patients and doctors knew which pill each person was taking, because the trial was not blinded. [1]

Why it matters. Roche has not said when it will ask regulators to approve divarasib; its next test is Krascendo 2, which pairs it with Merck's Keytruda as a first treatment against Keytruda with chemotherapy. [1][2]

AstraZeneca and HUTCHMED showed full results of SAFFRON, a final-stage trial, at ESMO on Sunday, and the New England Journal of Medicine, a leading medical journal, published them the same day. [3][4] Tagrisso is AstraZeneca's pill for lung cancers driven by a faulty EGFR gene, and many of these cancers later escape it by turning up a second growth signal, MET. [3] In 338 patients with high MET, adding HUTCHMED's MET-blocking pill savolitinib to Tagrisso kept 70% alive at one year, against 53% on chemotherapy. [3] Half were alive at 17.8 months, against 12.9. [3][4]

Why it matters. About a third of patients whose cancer escapes Tagrisso do so through high MET, said the trial's lead doctor, Shun Lu of Shanghai Chest Hospital. [3] The pair is already approved in China, and AstraZeneca has asked the US regulator to approve it as an all-pill treatment instead of chemotherapy. [3]

Akeso, a Chinese drugmaker, said its antibody ivonescimab with chemotherapy helped people with advanced biliary tract cancer live longer than AstraZeneca's Imfinzi with chemotherapy, the standard first treatment. [5][6] These cancers start in the bile ducts or the gallbladder, and fewer than 5% of people whose cancer has spread live five years. [6] Ivonescimab is one antibody that does two jobs: it frees the immune system and stops tumours growing new blood vessels. [5] In 682 patients in China, half were alive at 14.9 months, against 12.1 on Imfinzi. [5][6]

Why it matters. At 18 months, 44% were alive on ivonescimab against 32.5% on Imfinzi, and the result was shown in ESMO's top session. [5] The trial ran only in China, and Summit Therapeutics, a US company that holds the drug's rights in its own territories, notes it is not approved there. [6]

AstraZeneca showed full results for sone-ve, an antibody joined to a cell-killing poison, in advanced cancer of the stomach and food pipe. [7][8] The antibody seeks out claudin 18.2, a protein found on many of these cancer cells. [8] Patients who had already had two treatments lived a median 10 months on sone-ve, against 5 months on chemotherapy, and 10.6 against 6.4 across the whole trial. [7][8] The time before tumours grew, judged by reviewers who did not know the treatment, was 4.2 months against 3.8, too close to count as a win. [7]

Why it matters. AstraZeneca says the data are strong enough to take to regulators, and four of the 12 presentations in ESMO's top sessions featured its medicines. [7][9] The trial took patients with the protein on at least 25% of tumour cells, against 75% for the approved drug on this target, which AstraZeneca says could double who qualifies. [8]

Attackers killed a nurse and badly injured another health worker on Saturday in Bafwasende, a town in Congo's Tshopo province, as they answered an Ebola alert, the World Health Organization said. [16] Congo's health ministry counts more than 9,800 cases and more than 4,700 deaths since May, the deadliest Ebola outbreak in the country's history. [16] Responders say distrust of how Congo's government has handled the outbreak makes their work harder, and some people call Ebola a hoax. [16] In September a politician who defended the response was beaten to death in North Kivu. [16]

Why it matters. The Bundibugyo kind of Ebola behind this outbreak has no approved vaccine or specific treatment. [16] Local officials have not said who carried out the attack, and the WHO's Africa director said fear and false claims must never fuel violence. [16]

Uganda said on Sunday that citizens returning from Congo must spend 21 days in quarantine at their own expense. [17] Congolese travellers on non-essential trips will be sent back at their own cost, and screening is tighter at Entebbe airport and land borders. [17] Uganda declared its own outbreak over on 28 July and reports no active cases. [17][18] But the first Ebola patients in Kenya and Nigeria both passed through Entebbe airport on 3 October, the Africa CDC says. [18]

Why it matters. On 23 October the WHO advised against limits on travel or trade with affected countries, so Uganda's rule goes further than that advice. [16] Kenya is still trying to reach a Ugandan man listed as a contact of its first patient, Kenya's Daily Nation reported. [18]

A new analysis found that only 31% of 97 cancer uses approved in Europe from January 2022 to July 2026 offered a high benefit to patients, STAT reported on Friday. [15] It graded them with a scale from ESMO, the European cancer doctors' society, which rates how much a drug helps. [15] Of 63 cancer drugs, 19 had at least one high-benefit use, and nine reached the top grade. [15] Five drugmakers made more than half of the 30 high-benefit uses. [15]

Why it matters. Four of those five companies are based in China or Japan, which the researchers called a fundamental shift in where cancer medicines come from. [15] Two of Sunday's results, from Akeso and Innovent, come from Chinese drugmakers.

BioNTech and Bristol Myers Squibb showed first results for pumitamig, an antibody that blocks two targets at once, in lung cancer that had grown after immunotherapy and chemotherapy. [10][11] Given with docetaxel, an older chemotherapy, it shrank tumours in 36.7% of 30 patients who could be assessed. [10] Half of all 50 patients went 6.9 months before their cancer grew, against about 3.6 to 3.9 months for docetaxel alone in past studies. [10] Every patient got the pair, so there was no docetaxel-only group to compare. [10]

Why it matters. BioNTech bought Biotheus, the Chinese company that made pumitamig, for over $800 million, and Bristol Myers Squibb joined in a deal worth up to $11.1 billion. [11] BioNTech said on Thursday it will also test pumitamig with Gilead's breast cancer drug Trodelvy in a final-stage trial. [12]

Innovent Biologics, a Chinese drugmaker, showed updated early results at ESMO for IBI363, one protein that releases an immune brake called PD-1 and also carries IL-2, a signal that makes immune cells multiply. [13] It was given with chemotherapy to 69 people with untreated lung cancer low in PD-L1, a marker on tumours; immune drugs tend to work less well when it is low. [13] Tumours shrank in 47.4% to 86.4% of patients, depending on which of three dose groups they were in. [13]

Why it matters. How long patients live without tumour growth is not yet known, and a trial against Merck's Keytruda with chemotherapy is now running. [13] Takeda, a Japanese drugmaker, paid $1.2 billion up front a year ago for the rights outside China to this drug and a second one. [14]

A small trial at four hospitals in Italy found that adding an antibody called visugromab to the immune drug nivolumab before surgery cleared more bladder tumours, Nature Medicine reported on Saturday. [20] Visugromab blocks GDF-15, a signal that bladder tumours make in large amounts and that may stop immune drugs working. [20] No cancer was left at surgery in 5 of 15 patients on the pair, against 1 of 13 on nivolumab and a dummy drug. [20] The 31 patients could not have or refused cisplatin, the usual chemotherapy. [20]

Why it matters. Patients were not assigned to the groups at random and the trial was small, so it points to a bigger test rather than proving the pair works. [20]

The biggest biotech stock fund, iShares Biotechnology, rose 34% in the 12 months to Friday, and State Street's SPDR S&P Biotech fund rose 39%. [19] Biotech companies raised about $7.8 billion selling shares to the public for the first time this year, against $1.2 billion in all of 2025, according to the investment bank Locust Walk. [19] But licensing deals, where one company buys rights to another's drug, fell to a two-year low of about $48 billion in the third quarter. [19]

Why it matters. Chinese companies supplied 58% of this year's licensing value, up from 48% a year earlier, against 26% from the US and 8% from Europe and the UK. [19] Locust Walk's chief, Geoff Meyerson, says this is because share sales in Hong Kong have become much harder and Chinese biotechs are almost never bought outright. [19]

Immune drugs for cancer sometimes make the immune system attack the gut, liver or skin, and steroids do not always stop it. [21] A trial of 30 such patients, published in Nature Communications on Friday, tested photopheresis, in which blood is drawn, its white cells are treated with light and returned. [21] The side effects eased in 96.3% of cases, and the treatment caused no serious harm. [21] Every gut and skin case responded, and 13 of 15 liver cases did. [21]

Why it matters. Severe side effects force patients to pause a cancer drug that may be working and take drugs that dampen the immune system. [21] The trial had no comparison group, so it shows the method is safe and promising, not that it beats other options. [21]

Scientists at NYU Langone Health, a New York hospital, read nearly half a million single pancreatic cancer cells and found that each tumour holds several groups of cells with different DNA changes. [22] Some groups resist treatment and others spread more readily, the study in Nature Genetics on 13 October found. [22] A gene called MYC was most active in the most aggressive cells, and blocking it in lab cells turned them back to a milder kind. [22]

Why it matters. Nearly 85% of people with this cancer die within five years, and these shifting groups help explain why it so often stops responding to treatment. [22] The MYC result comes from cells in a dish, not from people. [22]

At ESMO on Saturday, Toni Choueiri of the Dana-Farber Cancer Institute, a Boston cancer hospital, said mistrust and false claims are a key challenge for any medicine made with mRNA. [23] He cited a 2022 survey in which 15% of people wrongly believed the mRNA Covid shots could change human DNA. [23] Some now call Merck and Moderna's melanoma treatment a personalised neoantigen therapy instead of a vaccine. [23] Full results of its trial will be published next month in the New England Journal of Medicine. [23]

Why it matters. The US government is backing cancer vaccines while it has sharply cut funding for mRNA vaccine research, STAT notes. [23] Moderna's chief, Stephane Bancel, says success against cancer will change how people see mRNA. [23]