Goldman Sachs updates ASCO latest clinical progress, three US pharmaceutical companies receive "Buy" rating

According to the Zhitong Finance APP, Goldman Sachs released a research report on June 2, updating relevant information obtained at the American Society of Clinical Oncology (ASCO) annual meeting, including the progress of drugs/therapies from pharmaceutical companies such as Amgen (AMGN.US), Regeneron Pharma (REGN.US), and Relay Therapeutics (RLAY.US) in clinical trials. The following are the specific details.

1. Amgen

Amgen announced detailed data on the positive results of its Phase 3 clinical trial of the targeted immunotherapy Imdelltra for the treatment of previously treated small cell lung cancer patients, showing that compared to second-line chemotherapy, this therapy can help patients extend their lifespan, has a more tolerable safety profile, and improves certain cancer-related symptoms.

The trial is a global Phase 3 randomized, controlled, open-label clinical trial DeLLphi-304, aimed at evaluating the efficacy and safety of Imdelltra in treating small cell lung cancer patients who experienced disease progression during or after single-agent platinum-based chemotherapy. A total of 509 patients were randomly assigned to receive Imdelltra (254 patients) or chemotherapy (255 patients).

In the planned interim analysis (data cutoff January 29, 2025), the trial achieved its primary overall survival endpoint and key secondary progression-free survival endpoint.

Compared to chemotherapy, Imdelltra significantly reduced the risk of death by 40% in small cell lung cancer patients who had previously attempted first-line platinum-based chemotherapy. The average survival time for patients in the Imdelltra group was 13.6 months, while for the chemotherapy group it was 8.3 months. All patient subgroups appeared to benefit, regardless of prior PD-1/L1 treatment, the presence of brain or liver metastases, or the type of chemotherapy previously received. In patients who had attempted PD-1/L1 inhibitors, Imdelltra reduced the risk of death by 39%. In PD-1/L1 treatment-naive patients, this figure was 35%.

Compared to chemotherapy, Imdelltra treatment reduced the risk of disease progression or death by 29%. The median progression-free survival was 4.2 months and 3.7 months, respectively. Additionally, compared to the chemotherapy group, Imdelltra significantly improved patient-reported outcomes for cancer-related symptoms such as dyspnea and cough.

The safety profile of Imdelltra was consistent with its known safety. In this trial, the incidence of grade 3 or higher adverse events was lower than that of the chemotherapy group (54% vs. 80%), and the incidence of adverse events leading to treatment discontinuation was also lower than that of the chemotherapy group (5% vs. 12%).

Data shows that Imdelltra is a bispecific δ-like ligand 3-directed T-cell engaging immunotherapy, which received accelerated approval from the U.S. Food and Drug Administration (FDA) in May 2024 for the treatment of previously treated extensive-stage small cell lung cancer patients. The latest trial data may help convert its accelerated approval into full approval.

Goldman Sachs has rated Amgen's stock as "Buy," with a 12-month target price of $400. This target price represents a 38% upside potential compared to the stock's closing price on June 3.

2. Regeneron Pharma

Regeneron announced preliminary results from two cohorts of the Ph1b LINKER-MM2 trial, which evaluates the efficacy of its bispecific antibody therapy linvoseltamab (linvo) in combination with two different proteasome inhibitors (PIs) — carfilzomib or bortezomib.

linvoseltamab + bortezomib: for the treatment of relapsed/refractory multiple myeloma (RRMM) patients

Data came from 24 patients (20 evaluable for efficacy), with a median follow-up time of 9 months. Six patients received 100 mg of linvoseltamab, and 18 patients received 200 mg, followed by bortezomib. At all dose levels, the linvoseltamab + bortezomib combination showed an 85% objective response rate (ORR) (17 out of 20 patients) and a 50% complete response rate (CR rate) (10 out of 20 patients) in heavily pretreated patient populations, with a 6-month progression-free survival (PFS) rate of 78% (of which 50% of patients had difficulty with prior Pl treatment). The LINKER-MM1 study showed that linvoseltamab as a monotherapy achieved a 71% ORR, with a median PFS not reached at 21.3 months, suggesting that combination therapy with bortezomib appears superior to monotherapy.

In terms of safety, 58% of patients experienced grade 1-2 cytokine release syndrome (CRS), with no CRS of grade 3 or higher. Four patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS, 1 grade 1, 3 grade 2). Seventy-five percent of patients experienced infections (38% grade 3 or higher). Two patients died due to adverse events — one patient died from pneumonia deemed related to treatment, occurring before the start of bortezomib treatment; another patient died from COVID-19, which was considered unrelated to treatment. A dose-limiting toxicity (DLT) of grade 3 cytomegalovirus reactivation was observed at the 200 mg dose level. All known adverse events were attributed to linvoseltamab or bortezomib, so no new side effects emerged after combination therapy.

Goldman Sachs stated that overall, considering the small number of patients and limited follow-up time, they are encouraged by the 85% ORR and early duration of response (DOR) and PFS results. Linvoseltamab (brand name Lynozyfic) was recently approved in the EU for the treatment of adults with relapsed/refractory (R/R) multiple myeloma who have received at least three prior lines of therapy. Regeneron is confident in the best-in-class characteristics of linvoseltamab, in addition to its potential to transition to earlier lines of therapy.

linvoseltamab + carfilzomib: for the treatment of relapsed/refractory multiple myeloma (RRMM) patients

Data came from 23 high-risk patients (21 evaluable for efficacy), all of whom had prior exposure to Pl (12 patients had at least one Pl-refractory prior treatment), with 39% aged over 75 11 patients received 100mg of linvoseltamab treatment, while 5 patients received either 150mg or 200mg of linvoseltamab, followed by a combination with carfilzomib. The median follow-up time was 15 months. The combination treatment of linvoseltamab + carfilzomib showed a 90% overall response rate (ORR) and a 76% complete response (CR) rate, with 5 out of 7 evaluable patients being minimal residual disease (MRD) negative. The estimated 12-month duration of response (DOR) was 87% (n=19; 95% confidence interval [CI]: 56% to 97%), and the estimated 12-month progression-free survival (PFS) rate was 83% (n=21; 95% CI: 55% to 94%).

In terms of safety, 61% of patients experienced any level of cytokine release syndrome (CRS), with no cases of grade 3 or higher CRS. 91% of patients experienced infections, with 45.3% being grade 3 or higher, including one case of death due to septic shock caused by secondary Escherichia coli infection. 83% of patients in this cohort received at least one dose of intravenous immunoglobulin (IVIG), which may reduce the risk of infection and warrants further investigation. One dose-limiting toxicity (DLT) of grade 4 thrombocytopenia was observed during tumor lysis syndrome at the 100mg linvoseltamab dose, and one case of grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) was observed at the 150mg dose (with grade 2 CRS), which resolved within one day of onset.

Goldman Sachs stated that overall, they are encouraged by the consistency and durability of the results and noted the safety of the individual drug. Regeneron plans to conduct a randomized Phase 3 registration study to investigate the combination of linvoseltamab + carfilzomib in comparison to standard treatment for relapsed/refractory multiple myeloma.

Goldman Sachs has a "Buy" rating on Regeneron Pharmaceuticals, with a 12-month target price of $804. This target price represents a 35% upside from the stock's closing price on June 3.

3. Relay Therapeutics

Relay announced the trial results of the PI3Kα inhibitor RLY-2608 in combination with fulvestrant for PIK3CA-mutated HR+/HER2- advanced breast cancer. As of the interim data on March 26, 2025, the trial included a total of 118 patients with locally advanced or metastatic breast cancer carrying PI3Kα mutations, of which 64 were treated at the recommended Phase 3 dose (RP3D) of 600mg twice daily on an empty stomach. All patients had received endocrine therapy and CDK4/6 inhibitors, with 44% having received at least two lines of treatment.

In terms of efficacy, with a median follow-up of 12.5 months, the median progression-free survival (PFS) for 52 evaluable RP3D patients was 10.3 months for all patients, 11.0 months for second-line patients (18.4 months for kinase mutation patients and 8.5 months for non-kinase mutation patients). The clinical benefit rate (CBR) for all patients (35 out of 52 evaluable patients) was 67%, with 12 out of 31 patients with measurable disease achieving partial response (PR; 39%). For 15 patients with measurable disease and kinase mutations, the overall response rate (ORR) was 67% Among the 15 patients who previously used fluvistrant, 6 (40%) achieved partial remission.

In terms of safety, the combination therapy was well tolerated, with a median dose intensity of 92% among 64 RP3D patients, and only two discontinued treatment due to treatment-related adverse events. Hyperglycemia was mostly grade 1, with 3% experiencing grade 3 hyperglycemia, and no grade 4/5 events. The incidence of grade 3 treatment-related adverse events was 36%.

Goldman Sachs expressed optimism regarding the 12.5-month follow-up data, with a median PFS of 9.2 months for all patients and 11.4 months for second-line patients. In comparison, AstraZeneca's capivasertib (Truqap) + fulvestrant phase III data showed a PFS of 5.5 months, a CBR of 56%, and an ORR of 26%. Therefore, the firm maintains a positive outlook on Relay's upcoming phase III study.

Goldman Sachs added that it looks forward to further data on the frontline triplet regimen of RLY-2608 with Pfizer's CDK4 selective inhibitor atirmociclib and the CDK4/6 inhibitor ribociclib, as well as progress in the vascular malformation indication.

Goldman Sachs has a "Buy" rating on Relay's stock, with a 12-month target price of $11. This target price represents a 234% upside from the stock's closing price on June 3.